| Coverage Policy Manual | |
| Policy #: | 2015016 |
| Category: | Radiology |
| Initiated: | May 2015 |
| Last Review: | November 2023 |
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| Focal Treatments for Prostate Cancer | |
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| Description: |
Prostate cancer is the second most common cancer diagnosed among men in the United States according to the National Cancer Institute, nearly 268,490 new cases are estimated to be diagnosed in the U.S. in 2022, associated with around 34,500 deaths (ACS, 2022). Autopsy studies in the pre-prostate-specific antigen (PSA) screening era identified incidental cancerous foci in 30% of men 50 years of age, with incidence reaching 75% at age 80 years (Dall’Era, 2008). However, the National Cancer Institute Surveillance Epidemiology and End Results Program data have shown that age-adjusted cancer-specific mortality rates for men with prostate cancer declined from 40 per 100,000 in 1992 to 19 per 100,000 in 2018. This decline has been attributed to a combination of earlier detection via PSA screening and improved therapies.
From a clinical standpoint, different types of localized prostate cancers may appear similar during initial diagnosis (Bangma, 2007). However, prostate cancer often exhibits varying degrees of risk progression that may not be captured by accepted clinical risk categories (eg, D’Amico criteria) or prognostic tools based on clinical findings (eg, PSA titers, Gleason grade, or tumor stage) (Johansson, 2004; Ploussard, 2011; Harnden, 2008; Brimo, 2013; Eylert, 2012). In studies of conservative management, the risk of localized disease progression based on prostate cancer-specific survival rates at 10 years may range from 15% to 20% to perhaps 27% at 20-year follow-up (Eastham, 2008; Bill-Axelson, 2005; Thompson, 2013; Albertsen, 2005). Among elderly men (≥70 years) with this type of low-risk disease, comorbidities typically supervene as a cause of death; these men will die from the comorbidities of prostate cancer rather than from cancer itself. Other very similar-appearing low-risk tumors may progress unexpectedly and rapidly, quickly disseminating and becoming incurable.
The divergent behavior of localized prostate cancers creates uncertainty whether to treat immediately (Borley, 2009; Freedland, 2011). A patient may choose definitive treatment up front (Ip, 2011). Surgery (radical prostatectomy) or external-beam radiotherapy are frequently used to treat patients with localized prostate cancer (Freedland, 2011; AUA, 2007). Complications most commonly reported with radical prostatectomy or external-beam radiotherapy and with the greatest variability are incontinence (0% to 73%) and other genitourinary toxicities (irritative and obstructive symptoms); hematuria (typically ≤5%); gastrointestinal and bowel toxicity, including nausea and loose stools (25% to 50%); proctopathy, including rectal pain and bleeding (10% to 39%); and erectile dysfunction, including impotence (50% to 90%) (AUA, 2007).
American Urological Association guidelines have suggested that patients with low- and intermediate-risk disease have the option of entering an “active surveillance” protocol, which takes into account patient age, patient preferences, and health conditions related to urinary, sexual, and bowel function (Sanda, 2017). With this approach, patients forego immediate therapy but continue regular monitoring until signs or symptoms of disease progression are evident, at which point curative treatment is instituted (Whitson, 2010; Albertsen, 2010).
Given significant uncertainty in predicting the behavior of individual localized prostate cancers, and the substantial adverse events associated with definitive treatments, investigators have sought a therapeutic middle ground. The latter seeks to minimize morbidity associated with radical treatment in those who may not actually require surgery while reducing tumor burden to an extent that reduces the chances for rapid progression to incurability. This approach is termed focal treatment, in that it seeks to remove, using any of several ablative methods described next, cancerous lesions at high-risk of progression, leaving behind uninvolved glandular parenchyma. The overall goal of any focal treatment is to minimize the risk of early tumor progression and preserve erectile, urinary, and rectal functions by reducing damage to the neurovascular bundles, external sphincter, bladder neck, and rectum (Jacome-Pita, 2014; Nguyen, 2011; Lindner, 2011; Iberti, 2011; Lecornet, 2010). Although focal treatments are offered as an alternative middle approach to manage localized prostate cancer, several key issues must be considered in choosing it. These include patient selection, lesion selection, therapy monitoring, and modalities used to ablate lesions.
A proportion of men with localized prostate cancer have been reported to have (or develop) serious misgivings and psychosocial problems in accepting active surveillance, sometimes leading to inappropriately discontinuing it (Tay, 2015). Thus, the appropriate patient selection is imperative for physicians who must decide whether to recommend active surveillance or focal treatment for patients who refuse radical therapy or for whom it is not recommended due to the risk/benefit balance (Passoni, 2014).
Proper lesion selection is a second key consideration in choosing a focal treatment for localized prostate cancer. Although prostate cancer is a multifocal disease, clinical evidence has shown that between 10% and 40% of men who undergo radical prostatectomy for a presumed multifocal disease actually have a unilaterally confined discrete lesion, which, when removed, would “cure” the patient (Scales, 2007; Mouraviev, 2007; Mouraviev, 2007). This view presumably has driven the use of regionally targeted focal treatment variants, such as hemiablation of half the gland containing the tumor, or subtotal prostate ablation via the “hockey stick” method (Muto, 2008). While these approaches can be curative, the more extensive the treatment, the more likely the functional adverse outcomes would approach those of radical treatments.
The concept that clinically indolent lesions comprise most of the tumor burden in organ-confined prostate cancer led to the development of a lesion-targeted strategy, which is referred to as “focal therapy” in this evidence review (Kasivisvanathan, 2013). This involves treating only the largest and highest grade cancerous focus (referred to as the “index lesion”), which has been shown in pathologic studies to determine the clinical progression of the disease (Mouraviev, 2007; Mouraviev, 2007). This concept is supported by molecular genetics evidence that suggests that a single index tumor focus is usually responsible for disease progression and metastasis (Liu, 2009; Guo, 2012). The index lesion approach leaves in place small foci less than 0.5 cm3 in volume, with a Gleason score less than 7, that are considered unlikely to progress over a 10- to 20-year period (Ahmed, 2008; Stamey, 1993; Nelson, 2006). This also leaves available subsequent definitive therapies as needed should disease progress.
Identification of prostate cancer lesions (disease localization) particularly the index lesion, is critical to the oncologic success of focal therapy; equally important to success is the ability to guide focal ablation energy to the tumor and assess treatment effectiveness. At present, no single modality reliably meets the requirements for all 3 activities (disease localization, focal ablation energy to the tumor, assessment of treatment effectiveness) (Passoni, 2014; Kasivisvanathan, 2013). Systematic transrectal ultrasound-guided biopsy alone has been investigated; however, it has been considered insufficient for patient selection or disease localization for focal therapy (van den Bos, 2014; Mayes, 2011; Sinnott, 2012; Gallina 2012; Briganti, 2012).
Multiparametric magnetic resonance imaging (mpMRI), typically including T1-, T2-, diffusion-weighted imaging, and dynamic contrast-enhanced imaging, has been recognized as a promising modality to risk-stratify prostate cancer and select patients and lesions for focal therapy (Tay, 2015; Kasivisvanathan, 2013; van den Bos, 2014). Evidence has shown mpMRI can detect high-grade, large prostate cancer foci with performance similar to transperineal prostate mapping using a brachytherapy template (Arumainayagam, 2013). For example, for the primary endpoint definition (lesion, ≥4 mm; Gleason score, ≥3+4), with transperineal prostate mapping as the reference standard, sensitivity, negative predictive value, and negative likelihood ratios with mpMRI were 58% to 73%, 84% to 89%, and 0.3 to 0.5, respectively. Specificity, positive predictive value, and positive likelihood ratios were 71% to 84%, 49% to 63%, and 2.0 to 3.44, respectively. The negative predictive value of mpMRI appears sufficient to rule out clinically significant prostate cancer and may have clinical use in this setting. However, although mpMRI technology has the capability to detect and risk-stratify prostate cancer, several issues constrain its widespread use for these purposes (e.g., mpMRI requires highly specialized MRI-compatible equipment; biopsy within the MRI scanner is challenging; interpretation of prostate MRI images requires experienced uroradiologists) and it is still necessary to histologically confirm suspicious lesions using transperineal prostate mapping (Dickinson, 2011).
Controversy exists about the proper endpoints for focal therapy of prostate cancer. The primary endpoint of focal ablation of clinically significant disease with negative biopsies evaluated at 12 months posttreatment is generally accepted according to a European consensus report (van den Bos, 2014). The clinical validity of an MRI to analyze the presence of residual or recurrent cancer compared with histologic findings is offered as a secondary endpoint. However, MRI findings alone are not considered sufficient in a follow-up (van den Bos, 2014). Finally, although investigators have indicated that PSA levels should be monitored, PSA levels are not considered valid endpoints because the utility of PSA kinetics in tissue preservation treatments has not been established (Ahmed, 1993).
Modalities Used to Ablate Lesions
Five ablative methods for which clinical evidence is available are considered herein: focal laser ablation; high-intensity focused ultrasound; cryoablation; radiofrequency ablation; and photodynamic therapy (Jacome-Pita, 2014; Nguyen, 2011; Iberti, 2011; Lecornet, 2010; Muto, 2008; Kasivisvanathan, 2013; Liu, 2009; Ahmed, 2008; van den Bos, 2014; NICE, 2019; NICE, 2012). Each method requires placement of a needle probe into a tumor volume followed by delivery of some type of energy that destroys the tissue in a controlled manner. All methods except focal laser ablation currently rely on ultrasound guidance to the tumor focus of interest; focal laser ablation uses MRI to guide the probe.
Focal Laser Ablation
Focal laser ablation refers to the destruction of tissue using a focused beam of electromagnetic radiation emitted from a laser fiber introduced transperineally or transrectally into the cancer focus. The tissue is destroyed through the thermal conversion of the focused electromagnetic energy into heat, causing coagulative necrosis. Other terms for focal laser ablation include photothermal therapy, laser interstitial therapy, and laser interstitial photocoagulation (Lee, 2014).
High-Intensity Focused Ultrasound
High-intensity focused ultrasound focuses high-energy ultrasound waves on a single location, which increases the local tissue temperature to over 80°C. This causes a discrete locus of coagulative necrosis of approximately 3x3x10 mm. The surgeon uses a transrectal probe to plan, perform, and monitor treatment in a real-time sequence to ablate the entire gland or small discrete lesions.
Cryoablation
Cryoablation induces cell death through direct cellular toxicity from disruption of the cell membrane caused by ice-ball crystals and vascular compromise from thrombosis and ischemia secondary to freezing below -30°C. Using a transperineal prostate mapping template, cryoablation is performed by transperineal insertion under transrectal ultrasound guidance of a varying number of cryoprobe needles into the tumor.
Radiofrequency Ablation
Radiofrequency ablation (RFA) uses the energy produced by a 50-watt generator at a frequency of 460 kHz. Energy is transmitted to the tumor focus through 15 needle electrodes inserted transperineally under ultrasound guidance. Radiofrequency ablation produces an increase in tissue temperature causing coagulative necrosis.
Photodynamic Therapy
Photodynamic therapy uses an intravenous photosensitizing agent, which distributes through prostate tissue, followed by light delivered transperineally by inserted needles. The light induces a photochemical reaction that produces reactive oxygen species that are highly toxic and causes functional and structural tissue damage (ie, cell death). A major concern with photodynamic therapy is that real-time monitoring of tissue effects is not possible, and the variable optical properties of prostate tissue complicate the assessment of necrosis and treatment progress.
Regulatory Status
Focal Laser Ablation
In 2010, the Visualase® Thermal Therapy System (Medtronic) and, in 2015, the TRANBERG® CLS|Laser fiber (Clinical Laserthermia Systems) were cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance for multiple indications including urology, at wavelengths from 800 to 1064 nm. In 2021, the FDA granted a breakthrough device designation to a novel artificial intelligence (AI)-enabled focal therapy system for the treatment of localized prostate cancer. The Avenda® Health Focal Therapy System combines an AI-based margin prediction software algorithm with focal laser ablation to deliver treatment directly to the prostate tumor. FDA product code: LLZ, GEX, FRN.
High-Intensity Focused Ultrasound
In October 2015, the Sonablate® 450 (SonaCare Medical) was cleared for marketing through the 510(k) process after approval of a de novo request and classification as class II under the generic name “high intensity ultrasound system for prostate tissue ablation”. This device was the first of its kind to be approved in the U.S. In November 2015, Ablatherm®-HIFU (EDAP TMS) was cleared for marketing by the FDA through the 510(k) process. In June 2018, EDAP received 510(k) clearance for its Focal-One® HIFU device designed for prostate tissue ablation procedures. This device fuses magnetic resonance and 3D biopsy data with real-time ultrasound imaging, allowing urologists to view detailed images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area.
Cryoablation
Some of the cryotherapy devices that are cleared for marketing by FDA through the 510(k) process for cryoablation of the prostate are: Visual-ICE® (Galil Medical), Ice Rod CX, CryoCare® (Galil Medical), and IceSphere (Galil Medical) and Cryocare® Systems (Endocare®; HealthTronics). FDA product code: GEH.
Radiofrequency Ablation
Radiofrequency ablation devices have been cleared for marketing by the FDA through the 510(k) process for general use for soft tissue cutting and coagulation and ablation by thermal coagulation. Under this general indication, RFA may be used to ablate tumors. FDA product code: GEI.
Photodynamic Therapy
The FDA has granted approval to several photosensitizing drugs and light applicators. Photofrin® (porfimer sodium) and psoralen are photosensitizers ultraviolet lamps used in the treatment of cancer. FDA has cleared ultraviolet lamps through the 510(k) process. FDA product code: FTC.
In 2020, an FDA advisory committee voted against recommending approval of padeliporfin di-potassium (Tookad®; Steba Biotech), a minimally invasive photodynamic therapy for localized prostate cancer, citing concerns that men with very low-risk disease would potentially choose this therapy instead of active surveillance, despite the unproven long-term benefits and harms of treatment.
Magnetic Nanoparticles
MagForce® USA, Inc. is conducting a clinical study evaluating NanoTherm® under an FDA Investigational Device Exemption (IDE) (NCT05010759). NanoTherm uses magnetic nanoparticles and an alternating magnetic field to create heat and local ablation in the ablation of prostate cancer.
Coding
There is no specific CPT code for these treatments. It is likely they are reported with CPT code 53899 unlisted procedure, urinary system or CPT code 55899 unlisted procedure, male genital system.
Effective 1/1/2021, CPT code 55880 was added.
55880: Ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU), including ultrasound guidance
Cryosurgical Ablation of Prostate Cancer is addressed in a separate policy # 2003002
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Policy/ Coverage: |
Effective August 1, 2021, for members of plans that utilize a radiation oncology benefits management program, Prior Approval is required for this service and is managed through the radiation oncology benefits management program.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Focal Treatment for Prostate Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria Focal Treatment for Prostate Cancer is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Localized Prostate Cancer and Current Management
Prostate cancer is the second most common cancer diagnosed among men in the United States. According to the National Cancer Institute (NCI), nearly 240,000 new cases are expected to be diagnosed in the United States in 2013 and are associated with around 30,000 deaths. Autopsy studies in the pre-PSA screening era have identified incidental cancerous foci in 30% of men 50 years of age, with incidence reaching 75% at age 80 years (Dall’Era, 2008). However, NCI Surveillance Epidemiology and End Results data show age-adjusted cancer-specific mortality rates for men with prostate cancer have declined from 40 per 100,000 in 1992 to 22 per 100,000 in 2010. This decline has been attributed to a combination of earlier detection via prostate specific antigen (PSA) screening and improved therapies.
Localized prostate cancers may appear very similar clinically at diagnosis (Bangma, 2007). However, they often exhibit diverse risk of progression that may not be captured by accepted clinical risk categories (eg, D’Amico criteria) or prognostic tools that are based on clinical findings, including PSA titers, Gleason grade, or tumor stage (Johansson, 2004; Ploussard, 2011; Harnden. 2008; Brimo, 2012; Eylert, 2012). In studies of conservative management, the risk of localized disease progression based on prostate cancer-specific survival rates at 10 years may range from 15% (Eastham, 2008; Bill-Axelson, 2005), to 20% (Thompson, 2013) to perhaps 27% at 20-year follow-up (Albertsen, 2005). Among elderly men (≥70 years) with this type of low-risk disease, comorbidities typically supervene as a cause of death; these men will die with prostate cancer present, rather than from the cancer. Other very similar-appearing low-risk tumors may progress unexpectedly rapidly, quickly disseminating and becoming incurable.
The divergent behavior of localized prostate cancers creates uncertainty whether or not to treat immediately (Borley, 2009; Freedland, 2011). A patient may choose definitive treatment upfront (Ip, 2011). Surgery (radical prostatectomy), or EBRT are most commonly used to treat patients with localized prostate cancer (Freedland, 2011; Thompson, 2007). Complications most commonly reported with radical prostatectomy or EBRT and with the greatest variability are incontinence (0%-73%) and other genitourinary toxicities (irritative and obstructive symptoms); hematuria (typically ≤5%); gastrointestinal and bowel toxicity, including nausea and loose stools (25%-50%); proctopathy, including rectal pain and bleeding (10%-39%); and erectile dysfunction, including impotence (50%-90%) (Thompson, 2007).
American Urological Association (AUA) guidelines suggest patients with low- and intermediate-risk disease have the option of entering a “active surveillance” protocol, that takes into account patient age, patient preferences, and health conditions related to urinary, sexual, and bowel function (Thompson, 2007). With this approach the patient will forgo immediate therapy, but continue regular monitoring until signs or symptoms of disease progression are evident, at which point curative treatment is instituted (Whitson, 2010; Albertsen, 2010).
Focal Treatment of Localized Prostate Cancer
Given the uncertainty in predicting behavior of individual localized prostate cancers, and the substantial adverse effects associated with definitive treatments in patients with such disease, investigators have sought a middle ground that seeks to minimize morbidity associated with radical treatment in those who may not actually require it while reducing tumor burden to an extent that reduces the chances for rapid progression to incurability. This approach is termed “focal treatment,” in that it seeks to remove - using any of several ablative methods described next in the Background of this Policy - cancerous lesions at high risk of progression, leaving behind uninvolved glandular parenchyma. The overall goal of focal treatment is to minimize the risk of early tumor progression and preserve erectile, urinary and rectal functions by reducing damage to the neurovascular bundles, external sphincter, bladder neck and rectum (Jacome-Pita, 2014; Nguyen, 2011; Lindner, 2011; Iberti, 2011; Lecornet, 2010). Although focal treatment is offered as an alternative middle approach to management of localized prostate cancer, several key issues must be considered in choosing it. These include patient selection, lesion selection, therapy monitoring, and the modality used to ablate lesions.
A proportion of men with localized prostate cancer have been reported to have, or develop, serious misgivings and psychosocial problems in accepting active surveillance, sometimes leading to inappropriately discontinuing it (Tay, 2015). Thus, appropriate patient selection is imperative for physicians who must decide whether to recommend active surveillance or focal treatment for individual patients who refuse radical therapy or for whom it is not recommended due to the adverse balance of certain harms with unclear long-term benefit (Passoni, 2014).
Proper lesion selection is a second key consideration in choosing to undertake focal treatment of localized prostate cancer. Although prostate cancer has always been regarded as a multifocal disease, clinical evidence shows that between 10% and 40% of men who undergo radical prostatectomy for presumed multifocal disease actually have a unilaterally confined discrete lesion which when removed would “cure” the patient (Scales, 2007; Mouraviev, 2007a; Mouravie, 2007b). This view presumably drove the use of region-targeted focal treatment variants, such as hemi-ablation of the half of the gland containing tumor, or subtotal prostate ablation via the “hockey stick” method (Muto, 2008). While these approaches could be curative, the more extensive the treatment, the more likely the functional adverse outcomes would approach those of radical treatments.
The concept that clinically indolent lesions usually comprise most of the tumor burden in a patient with organ-confined prostate cancer led to development of the lesion-targeted strategy, which is referred to as “focal therapy” in this Policy (Kasivisvanathan, 2013). This involves treating only the largest and highest grade tumor (referred to as the “index lesion”), which has been shown in pathologic studies to determine clinical progression of disease (Mouraviev, 2011; Mouraviev, 2009). This concept is supported by molecular genetics evidence that suggests a single index tumor focus is usually responsible for disease progression and metastasis (Liu, 2009; Guo, 2012). The index lesion approach leaves in place small foci less than 0.5 cm3 in volume, with Gleason score less than 7 that are considered unlikely to progress over a 10- to 20-year period (Ahmed, 2008; Stamey, 1993; Nelson, 2006). This also leaves available subsequent definitive therapies as needed should disease progress.
Identification of prostate cancer lesions - disease localization - particularly the index lesion, is critical to oncologic success of focal therapy. The ability to guide focal ablation energy to the tumor, and assess treatment effectiveness, are additionally important to treatment success. At present, no single modality meets the requirements for all three activities (Passoni. 2014; Kasivisvanathan, 2013). Systematic transrectal ultrasound (TRUS)‒guided biopsy alone has been investigated, but is considered insufficient for the purpose of patient selection and disease localization for focal therapy (van den, 2014; Mayes, 2011; Sinnott, 2012; Gallina, 2012; Briganti, 2012). A 5mm transperineal prostate mapping (TPM) biopsy using a brachytherapy template is the current recommended standard by the European Association of Urology in their 2012 guidelines (Heidenreich, 2015). TPM can provide 3-dimensional coordinates of cancerous lesions, and has about 87% to 95% accuracy rates in detecting and ruling out clinically significant cancer of all sizes (Crawford, 2013; Hu. 2012). However, TPM is resource intensive, requires general anesthesia, and has been associated with adverse events including urinary retention (6%), prostatitis (4%), and local events such as perineal hematoma, bruising or pain (5%) (Tisvian, 2013). The risks of complications of general anesthesia, and the cost of processing multiple biopsy specimens, have been considered to limit the practicality and widespread applicability of this approach (Tay, 2015).
Multi-parametric magnetic resonance imaging (mp-MRI), typically including T1, T2, diffusion-weighted imaging and dynamic contrast-enhanced imaging, has been recognized as a promising modality to risk-stratify prostate cancer and select patients and lesions for focal therapy (Tay, 2015; Kasivisvanathan, 2013; van den, 2014). Evidence is available to show mp-MRI can detect high grade, large prostate cancer foci with performance similar to TPM (Arumainayagam, 2013). In this cohort study, for the primary end point definition (lesion, ≥4 mm; and Gleason score, ≥3+4), with TPM as the reference standard, sensitivity, negative predictive value, and negative likelihood ratios with mp-MRI were 58% to 73%, 84% to 89%, and 0.3 to 0.5, respectively. Specificity, positive predictive value, and positive likelihood ratios were 71% to 84%, 49% to 63%, and 2.0 to 3.44, respectively. The negative predictive value of mp-MRI appears sufficient to rule out clinically significant prostate cancer and may have clinical use in this setting. However, although mp-MRI technology has capability to detect and risk-stratify prostate cancer, several issues constrain its widespread use for these purposes. Thus, it is still necessary to histologically confirm suspicious lesions using TPM; mp-MRI requires highly specialized MRI-compatible equipment; biopsy within the MRI scanner is challenging; and, interpretation of prostate MRI images requires experienced uro-radiologists (Dickinson, 2011).
Some controversy exists as to the proper end points for focal therapy of prostate cancer. The primary end point of focal ablation of clinically significant disease with negative biopsies evaluated at 12 months after treatment is generally agreed on according to a European consensus report (van den, 2014). The clinical validity of MRI to analyze the presence of residual or recurrent cancer compared with histologic findings is offered as a secondary end point. However, MRI findings alone are not considered sufficient in follow-up. Finally, although investigators indicate PSA levels should be monitored, they are not considered as valid end points because the utility of PSA kinetics in tissue preservation treatments has not been established (Ahmed, 2008).
Methods Used for Focal Treatment of Localized Prostate Cancer
Five ablative methods for which clinical evidence is available are considered in this Policy: FLA; HIFU; cryoablation; RFA; and PDT (Jacome-Pita, 2014; Nguyen, 2011; Iberti, 2011; Lecornet, 2010; Muto, 2008; Kasivisvanathan, 2013; Ahmed, 2008; van den, 2014; NICE, 2012a, NICE, 2012b). Each method requires placement of a needle probe within a tumor volume followed by delivery of some type of energy that causes destruction of the tissue in a controlled manner. All of these methods currently rely on ultrasound guidance to the tumor focus of interest.
Focal laser ablation refers to the destruction of tissue using a focused beam of electromagnetic radiation emitted from a laser. It is accomplished through transperineal or transrectal introduction of a laser fiber into the cancer focus, with emission of energy. Tissue is destroyed by FLA through thermal conversion of the focused electromagnetic energy into heat, causing coagulative necrosis. Other terms for FLA include photothermal therapy, laser interstitial therapy, and laser interstitial photocoagulation (Lee, 2014).
High-intensity focused ultrasound (US) works by focusing high-energy US waves on a single location, which increases the local tissue temperature to over 80°C. This causes a discrete locus of coagulative necrosis of approximately 3 x 3 x 10 mm. The surgeon uses a transrectal probe to plan, carry out, and monitor treatment in a real-time sequence to ablate the entire gland, or small discrete lesions.
Cryoablation induces cell death through direct cellular toxicity from disruption of the cell membrane caused by ice-ball crystals and vascular compromise from thrombosis and ischemia secondary to freezing below -30°C. It is performed by transperineal insertion under TRUS guidance of a varying number of cryoprobe needles into the tumor, using a TPM template.
Radiofrequency thermal ablation (RFA) uses energy produced by a 50-watt generator with a frequency of 460 kHz. The energy is transmitted to the tumor focus through 15 needle electrodes inserted transperineally under US guidance into the tissue. It produces an increase in tissue temperature causing coagulative necrosis.
PDT involves the use of an intravenous photosensitizing agent that distributes to prostate tissue, followed by delivery of light via transperineally inserted needles. The light induces a photochemical reaction that causes production of reactive oxygen species that are highly toxic and reactive with tissue causing functional and structural damage, hence cell death. A major concern with PDT is that real-time monitoring of tissue effects is not possible, and the variable optical properties of prostate tissue complicate assessment of necrosis and treatment progress.
Systematic Review
A recent, high-quality systematic review (SR) published by Valerio et al in 2014 compiles the bulk of evidence available in the literature on the technologies included in this Policy.52 This SR was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Liberati, 2009). Only studies that reported actual focal-therapy outcomes were included. Specific categories of data to be collected were prespecified. The electronic database searches for this SR included MEDLINE, EMBASE, Web of Science, and the Cochrane Review database. The search strategy was well-documented, dating from inception of each database through October 31, 2012. Study selection criteria were prespecified, with dual review and data extraction, and senior author arbitration as needed. The quality of included studies was assessed according to the Oxford Centre for Evidence-based Medicine level of evidence for therapy. This SR and its summarized statistics serve as the basis for this Policy. Because no evidence exists to directly compare focal treatments, individual studies are not reported in detail, nor are ablative methods discriminated.
A total of 25 series were included that evaluated focal therapy in the primary setting. The quality of evidence was low to medium, with no study yielding a level of evidence greater than 2b (individual cohort study). Twelve series used high-intensity focused ultrasound (HIFU) (N=226); 6 series (N=1400) used cryoablation (1 study included 1160 of the 1400); 3 used focal laser ablation (FLA) (N=16); 1 used radiofrequency ablation (RFA) (N=14); and 1 used photodynamic therapy (PDT) (N=6). In 2 series focal treatments were mixed or included brachytherapy.
Patients in 12 series included in this SR had disease defined as low risk (n=1109 [56%]), intermediate risk (n=704 [36%]), and high risk (n=164 [8%]); risk categories were not available in 13 series. Median age of patients in the studies ranged from 56 years to 73 years. The prostate specific antigen (PSA) level of patients ranged from 3.8 to 24 ng/mL. An individual Gleason score was available in 20 series, with 1503 men having Gleason score <6; 521 with Gleason score 7; and, 82 with Gleason score higher than 8. Median follow-up periods for the reported focal therapy series were 0 to 10.6 years. Disease was localized as follows: transrectal ultrasound (TRUS) biopsy in 2 series; TRUS biopsy with Doppler ultrasound (US) in 2 series; TRUS biopsy plus magnetic resonance imaging (MRI) in 6 series; TMB and multiparametric MRI (mp-MRI) in 4 series; preoperative assessment was not reported in 11 studies.
In all studies where such data were reported in the Valerio SR, all known areas of cancer were treated; in no study was it explicitly stated that the index lesion was ablated and that other lesions were left untreated. Biochemical control based on PSA levels was reported in 5 series using the RTOG-ASTRO Phoenix Consensus Conference criteria (Roach, 2006). Other definitions used to define biochemical control were ASTRO (5 series), Stuttgart (1 series) and Phoenix plus PSA velocity greater than 0.75 ng/mL annually (1 series). Biochemical control rates ranged from 86% at 8-year follow-up (n=318) to 60% at 5-year (n=56). Because the follow-up was too short, progression to metastatic disease was not reported in most of the studies in the Valerio review; in those where information was available, metastatic progression rates were very low (0%-0.3%). Although a cancer-specific survival rate of 100% was reported in all series, this must be considered in the context of the small numbers of patients in individual studies and the short follow-up (only 3 studies had follow-up >5 years).
Across all studies, the median length of hospital stay was 1 day; other perioperative outcomes were poorly reported. Across studies, the most frequent complications associated with treatment of prostate cancer-urinary retention, urinary stricture, and urinary tract infection-occurred in 0% to 17%, 0% to 5%, and 0% to 17%, respectively, of patients. Only 5 studies reported all 3 complications. Validated questionnaires were used in 9 series to report urinary functional outcomes; physician-reported rates were used in 5 studies. According to questionnaires, the pad-free continence rate varied between 95% and 100%, whereas the range of leak-free rates was 80% to 100%. Validated questionnaire data showed erectile functional rates in 54% to 100%, while physician-reported data showed erectile functional rates of 58% to 85%. Other adverse outcomes were poorly reported, particularly quality-of-life data, with only 3 studies reporting the latter.
The literature review prepared for this Policy extended beyond the ending date stated for the Valerio SR. This extended search did not identify additional articles that would affect the conclusions in the Policy.
Some currently unpublished trials that might influence this policy are listed below:
Ongoing
No comparative evidence is available that assesses the use of the focal ablation techniques addressed in this Policy versus current standard treatment of prostate cancer, and therefore, no conclusions can be drawn between outcomes of focal therapies versus radical treatments versus active surveillance. In addition, no studies have been conducted that examine which, if any, of the focal techniques leads to better functional and oncologic outcomes. The body of evidence on the use of focal therapies for localized prostate cancer comprises case series or other observational studies; they are highly heterogeneous and inconsistently report clinical outcomes. Although high cancer-specific survival rates have been reported, the short follow-up periods and small sample sizes preclude conclusions on the effectiveness of any of these techniques. In addition, there is no standardization as to which and how many identified cancerous lesions should be treated. Although the adverse effect rates associated with focal therapies appear to be superior to those associated with radical treatments such as radical prostatectomy or external beam radiation therapy, the evidence is limited in its reporting and scope.
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
The National Comprehensive Cancer Network guidelines for prostate Cancer (v1.2015) state that cryosurgery (cryotherapy or cryoablation) is an evolving minimally invasive therapy that achieves damage to tumor tissue through local freezing.
National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (NICE) issued guidance on the use cryoablation for localized prostate cancer in 2012 (NICE, 2012a). The conclusion was that current evidence on focal therapy using cryoablation for localized prostate cancer raises no major safety concerns. However, evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
NICE also issued guidance on the use of focal therapy using HIFU for localized prostate cancer in 2012 (NICE, 2012b).The conclusion was that current evidence on HIFU for localized prostate cancer raises no major safety concerns. However, evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
American Urological Association
The American Urological Association (AUA) issued guidelines on the management of clinically localized prostate cancer in 2007 which were reviewed and validity confirmed in 2011 (AUA, 2011). AUA guidelines include the following recommendation regarding focal treatments: In addition to treatment modalities described and evaluated (eg, radical prostatectomy, external beam radiation, active surveillance) by the panel, a number of additional treatments, as well as combinations of treatments have been used for the management of clinically localized prostate cancer. These treatments include cryotherapy, HIFU, high-dose interstitial prostate brachytherapy, and combinations of treatments (eg, EBRT, interstitial prostate brachytherapy). The panel did not include other treatment options due to a combination of factors, including limited published experience and short-term follow up.
National Cancer Institute
The National Cancer Institute (NCI) updated their information on prostate cancer treatments in 2014 (NCI, 2014). NCI indicates cryotherapy and HIFU are new treatment options currently being studied in national trials. There is no recommendation for or against these treatments.
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force published recommendations for prostate cancer screening. However, there are no recommendations for focal treatment of prostate cancer.
2016 Update
A literature search conducted through February 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Clinical Studies
A matched cohort study published in 2015 included 317 men who underwent focal cryoablation with 317 men who underwent whole-gland cryoablation (Mendez, 2015). Patients in the study were entered in the Cryo Online Data (COLD) registry between 2007 and 2013. The median age at the time of the procedure was 66±7 [SD] years, and median follow-up time was 58 months. All patients were preoperatively potent men who had low-risk disease according to the D'Amico risk criteria and were matched according to age at surgery. Outcomes included biochemical recurrence (BCR) free-survival, defined according to the American Society for Radiation Oncology (ASTRO) and Phoenix criteria and assessed by Kaplan-Meier curves. Only patients with prostate-specific antigen (PSA) nadir data were included in oncologic outcome analysis. Functional outcomes were assessed at 6, 12, and 24 months after the procedure for erectile function (defined as ability to have intercourse with or without erectile aids), urinary continence, urinary retention, and rates of fistula formation. After surgery, 30% (n=95) and 17% (n=55) of the men who underwent whole-gland cryoablation and focal cryoablation, respectively, underwent biopsy, with positive biopsy rates of 12% and 14%, respectively. BCR-free survival rates at 60 months according to the Phoenix definition were 80% and 71% in the whole-gland and focal therapy cohorts, respectively, with a hazard ratio of 0.827 (p > 0.1). According to the ASTRO definition, BCR-free survival was 82% and 73%, respectively (p > 0.1). Erectile function data at 24 months were available for 172 whole-gland and 160 focal therapy treated men. Recovery of erection function was achieved in 47% and 69% of patients in the whole-gland and focal therapy cohorts, respectively (p=0.001). Urinary function data at 24 months were available for 307 whole-gland and 313 focal therapy patients. Urinary continence rates were 99% and 100% for the whole-gland and focal therapy groups, respectively (p=0.02). Urinary retention at 6, 12, and 24 months was reported in 7%, 2%, and 0.6%, respectively, in the whole-gland treated patients versus 5%, 1%, and 0.9%, respectively, in the focal therapy cohort. One fistula was reported in each group.
Summary of Evidence
The evidence for focal ablation therapy in patients who have primary, localized prostate cancer includes 1 high-quality systematic review, 1 registry cohort study, and numerous observational studies. Relevant outcomes include overall survival (OS), disease-specific survival (DSS), symptoms, change in disease status, functional outcomes, quality of life, treatment-related mortality and treatment-related morbidity.
The evidence is highly heterogeneous and inconsistently reports clinical outcomes. No prospective, comparative evidence is available on the use of any focal ablation technique described in this evidence review versus current standard treatment of localized prostate cancer, including radical prostatectomy, external beam radiotherapy, or active surveillance. Methods have not been standardized to determine which and how many identified cancerous lesions should be treated for best outcomes. No evidence supports which, if any, of the focal techniques leads to better functional outcomes. Although high DSS rates have been reported, the short follow-up periods and small sample sizes preclude conclusions on the effect of any of these techniques on OS rates. The adverse effect rates associated with focal therapies appear to be superior to those associated with radical treatments such as radical prostatectomy or external beam radiotherapy, however, evidence is limited in its quality, reporting and scope.
Therefore, the evidence is insufficient to determine the effects of the technology on health outcomes.
2017 Update
A literature search conducted using the MEDLINE database through April 2017 did not reveal any new information that would prompt a change in the coverage statement. A summary of the key identified literature is summarized below.
Cryoablation
In 2016, Lian et al reported long-term results of a case series of 40 low- to intermediate-risk patients treated with primary focal cryoablation between 2006 and 2013 by a single urologist in China (Lian, 2016). Biochemical recurrence was defined using the Phoenix definition and treatment failure was defined as at least 1 positive biopsy or BCR. Mean follow-up was 63 months (range, 12-92 months). Two (5%) of 40 patients met the criteria for biochemical failure and 4 (10%) patients experienced treatment failure. Of the men who were potent before cryotherapy, 20 (77%) remained potent after treatment. Ninety-eight percent of the men were completely continent during follow-up.
Laser Ablation
Additional case series and nonrandomized studies have assessed of focal laser ablation (Lepor, 2015; Ward, 2012) since the Valerio review. Studies were small (range, 8-25 men), single arm, lacked long-term follow-up (range, 3-6 months) and did not report clinical outcomes (eg, progression-free survival, overall survival).
Photodynamic Therapy
Preliminary results from a trial of TOOKAD, a soluble vascular-targeted photodynamic therapy (VTP), were presented in 2016 at the 31st Annual European Association of Urology Congress but have not yet been published. A total of 413 men with low-risk prostate cancer were randomized and followed for 2 years (206 in VTP plus active surveillance; 207 in active surveillance without VTP) (Emberton, 2016). It was reported that 28% of the patients in the VTP group versus 58% of the control group experienced disease progression (hazard ratio, 0.34; 95% confidence interval, 0.24 to 0.46; p<0.001) and more patients in the VTP group (49%) versus surveillance group (14%) had negative biopsies at 2 years. These results cannot be reviewed in full until publication.
Additional nonrandomized studies have assessed of photodynamic therapy since the Valerio review. A prospective, multicenter phase 2/3 trial by Taneja et al treated 30 men using photodynamic therapy. Follow-up was limited to 6 months and trialists did not report important clinical outcomes (eg, progression-free survival, overall survival) (Taneja, 2016).
The National Comprehensive Cancer Network guidelines for prostate cancer (v.3.2016) state that cryosurgery (cryotherapy or cryoablation) is an “evolving minimally invasive therapy that damages tumor tissue through local freezing.” It further states that “other emerging therapies such as high intensity focused ultrasound (HIFU) and vascular-targeted photodynamic (VTP), also warrant further study” (NCCN, 2016).
In 2014, NICE issued guidance on diagnosis and management of prostate cancer. The recommendations stated that neither cryotherapy or HIFU should be offered to men with localized prostate cancer or locally advanced prostate cancer outside of controlled trials comparing their use with established interventions NICE, 2014.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Urological Association et al
The American Urological Association, along with the American Society for Radiation Oncology and the Society for Urologic Oncology, updated their joint guidelines on the management of clinically localized prostate cancer in 2017 (Sanda, 2017). The guidelines included the following recommendation on focal treatments:
“Clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound (HIFU) that these interventions are not standard care options because comparative outcome evidence is lacking. (Expert Opinion)”
“Clinicians should inform intermediate-risk prostate cancer patients who are considering focal therapy or HIFU that these interventions are not standard care options because comparative outcome evidence is lacking. (Expert Opinion)”
“Cryosurgery, focal therapy and HIFU treatments are not recommended for men with high-risk localized prostate cancer outside of a clinical trial. (Expert Opinion)”
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
The National Comprehensive Cancer Network guidelines for prostate cancer (v.2.2019) recommend cryosurgery or high-intensity focused ultrasound (HIFU) as options for radiotherapy recurrence for nonmetastatic disease; cryosurgery is not recommended for the initial treatment of localized prostate cancer (NCCN, 2019).
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
An RCT of padeliporfin (a photodynamic therapy) versus active surveillance in men with low-risk prostate cancer was published by Azzouzi et al (Azzouzi, 2017); however, an FDA Advisory Committee voted against the approval of this agent in 2020.
Bates et al undertook a PRISMA-adhering systematic review that evaluated the evidence base (from January 2000 to June 2020) for focal therapy as a treatment strategy for men with histologically proven, clinically localized prostate cancer as compared to standard management options (Bates, 2021). Focal therapy interventions included high-intensity focused ultrasound (HIFU), vascular targeted photodynamic therapy, laser ablation, thermal ablation, focal brachytherapy, radiofrequency waves, microwave ablation, focal external-beam radiotherapy, and irreversible electroporation. The comparator intervention included any standard management option such as radical prostatectomy, external beam radiotherapy, whole gland brachytherapy, and active surveillance/monitoring. Overall, 5 articles reporting on 4 primary comparative studies (1 RCT and 3 retrospective nonrandomized comparative studies; N=3961) and 10 eligible systematic reviews were identified. The RCT compared a vascular targeted photodynamic therapy (padeliporfin) versus active surveillance among patients with low-risk prostate cancer and concluded that patients who underwent photodynamic therapy had less progression (28% vs. 58%; adjusted hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.24 to 0.46; p<.0001) and needed less radical therapy (6% vs. 29%; p<.0001) at 24 months (Azzouzi, 2017). Despite these "positive" results, an FDA staff analysis cited issues with the trial design, endpoints, missing data, and adverse events of padeliporfin therapy, resulting in the decline to recommend for approval by the FDA advisory committee. One retrospective study comparing focal HIFU with robotic radical prostatectomy found no significant difference in treatment failure at 3 years, with better continence and erectile function recovery with HIFU. The other 2 retrospective cohort studies compared focal laser ablation with radical prostatectomy and external beam radiotherapy and reported significantly worse oncologic outcomes with the focal treatment. Regarding the included systematic reviews, virtually all concluded that there was insufficient high certainty evidence to make definitive conclusions regarding the clinical effectiveness of focal therapy. The authors concluded that the "certainty of the evidence regarding the comparative effectiveness of focal therapy as a primary treatment for localized prostate cancer was low, with significant uncertainties" and that "until higher certainty evidence emerges...focal therapy should ideally be performed within clinical trials or well-designed prospective cohort studies."
Additional case series and nonrandomized studies have assessed focal laser ablation54,55,56, (Lepor, 2015; Natarajan, 2016; Mehralivand, 2021). In general, studies were small (range, 8 to 25 men), single-arm, lacked long-term follow-up (range, 3 to 6 months) and did not report clinical outcomes (eg, progression-free survival, OS). A recent 5-year follow-up of 30 men who had undergone focal laser ablation for localized prostate cancer revealed that 25 (83%) remained free from failure over a median of 71 months (Lepor, 2015; Chao, 2021). Among these patients, 10 (40%) developed in-field recurrence, with 9 undergoing salvage partial gland ablation with various focal treatments.
Nahar et al prospectively reported on the short-term outcomes of focal HIFU as a primary treatment of localized prostate cancer in 52 patients at a single center, with a minimum follow-up of 12 months (Nahar, 2020). Of the 30 patients who underwent biopsy post-ablation, 25 (83.3%) had negative and 5 (16.7%) had positive in-field results. Four (13.3%) patients had a de novo positive out-of-field biopsy and negative in-field biopsy. Prostate-specific antigen was significantly reduced (p<.001) below 2 ng/dL at the 3, 6, 9, and 12 month follow-up in 35 (76.1%), 27 (73%), 21 (72.4%), and 13 (56.5%) patients, respectively. Only 5 major complications were noted in 4 patients; all 4 required transurethral resection of necrotic tissue blocking the bladder outlet after HIFU and 1 had concurrent epididymoorchitis complicated with scrotal abscess requiring incision and drainage. Additionally, urinary symptoms returned to near baseline within 3 to 6 months and sexual function returned to baseline at 12 months.
The National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer (v.2.2021 ) recommend only cryosurgery and high-intensity focused ultrasound (HIFU) as local therapy options for radiotherapy recurrence in the absence of metastatic disease. Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments to radiation or radical prostatectomy (NCCN, 2021).
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
American Urological Association guidelines state that for patients with low-risk prostate cancer, clinicians should recommend active surveillance (Eastham, 2022).
The American Urological Association, in collaboration with the American Society for Radiation Oncology (ASTRO) with additional representation from the American Society of Clinical Oncology (ASCO), and Society of Urologic Oncology (SUO) published updated guidelines on the management of clinically localized prostate cancer in 2022 (Eastham, 2022). The guidelines included the following recommendation on focal treatments:
Hopstaken et al reported on an updated systematic review on focal therapy in localized prostate cancer in terms of functional and oncological outcomes that included 72 studies published between October 2015 and December 31, 2020 (Hopstaken, 2022). Of the included studies, 27 reported on HIFU, 9 on irreversible electroporation, 11 on cryoablation, 8 each on focal laser ablation and focal brachytherapy, 7 on photodynamic therapy, 2 on RFA, and 1 on prostatic artery embolization. Results revealed photodynamic therapy and HIFU to have potentially promising results. HIFU studies reported a median of 95% pad-free (regarding continence) patients and a median of 85% of patients with no clinically significant cancer in the treated area. No changes in continence were noted and a median of 90% of patients were without clinically significant cancer in the treated area among those receiving photodynamic therapy. Both treatments were well-tolerated. Despite these positive results, the authors noted that the majority of studies concerning focal therapy are still in an early research stage and that definitive proof of oncological effectiveness of focal therapy against standard of care is still pending.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Duwe et al described a prospective series of 29 patients with unilateral prostate cancer treated with focal HIFU between 2016 and 2021 at a single institution in Germany (Duwe, 2023). Median follow-up after HIFU was 23 months. Median age at time of HIFU was 67 years. Prostate cancer was detected in 13/29 (45%) patients histologically at one year. Another 7/29 patients (24%) were diagnosed with prostate cancer at two years. One patient developed local metastatic disease 2 years after HIFU. 70% of patients maintained sufficient erectile function for intercourse and 97% reported maintenance of urinary continence.
Reddy et al reported results of 1379 participants with 6 months or more of follow-up in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 2005-2020 in 13 centers in the United Kingdom (Reddy, 2022). Median follow-up was 32 months; 325 (24%) participants had 5 or more years of follow-up. The median age was 66 years. Failure-free survival at 7 years was 69% (95% CI, 64% to 74%). 252 participants had repeat focal treatment due to residual or recurrent cancer. 92 participants required salvage whole-gland treatment.
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National Institute for Health and Care Excellence (NICE).(2015) Prostate cancer: diagnosis and management (CG175). 2014; https://www.nice.org.uk/guidance/cg175/resources/prostate-cancer-diagnosis-and-management-35109753913285. Accessed August 8, 2016. Ahmed HU, Emberton M.(2008) Active surveillance and radical therapy in prostate cancer: can focal therapy offer the middle way? World J Urol. Oct 2008;26(5):457-467. PMID 18704441 Albertsen PC, Hanley JA, Fine J.(2005) 20-year outcomes following conservative management of clinically localized prostate cancer. JAMA. May 4 2005;293(17):2095-2101. PMID 15870412 Albertsen PC.(2010) Treatment of localized prostate cancer: when is active surveillance appropriate? Nat Rev Clin Oncol. Jul 2010;7(7):394-400. PMID 20440282 American Cancer Society (ACS).(2022) Key statistics for prostate cancer. January 12, 2022. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed August 1, 2022 American Urological Association (AUA).(2015) Guideline for the Management of Clinically Localized Prostate Cancer. 2011; https://www.auanet.org/education/guidelines/prostate-cancer.cfm. Accessed March, 2015. National Cancer Institute. Prostate Cancer Treatment, Treatment Option Overview. 2014; http://www.cancer.gov/cancertopics/pdq/treatment/prostate/Patient/page4#_172. Accessed March, 2015. Arumainayagam N, Ahmed HU, Moore CM, et al.(2013) Multiparametric MR imaging for detection of clinically significant prostate cancer: a validation cohort study with transperineal template prostate mapping as the reference standard. Radiology. Sep 2013;268(3):761-769. PMID 23564713 Azzouzi AR, Vincendeau S, Barret E, et al.(2017) Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. Feb 2017; 18(2): 181-191. PMID 28007457 Bangma CH, Roemeling S, Schroder FH.(2007) Overdiagnosis and overtreatment of early detected prostate cancer. World J Urol. Mar 2007;25(1):3-9. PMID 17364211 Bates AS, Ayers J, Kostakopoulos N, et al.(2021) A Systematic Review of Focal Ablative Therapy for Clinically Localised Prostate Cancer in Comparison with Standard Management Options: Limitations of the Available Evidence and Recommendations for Clinical Practice and Further Research. Eur Urol Oncol. Jun 2021; 4(3): 405-423. PMID 33423943 Bill-Axelson A, Holmberg L, Ruutu M, et al.(2005) Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. May 12 2005;352(19):1977-1984. PMID 15888698 Borley N, Feneley MR.(2009) Prostate cancer: diagnosis and staging. Asian J Androl. Jan 2009;11(1):74-80. PMID 19050692 Briganti A, Tutolo M, Suardi N, et al.(2012) There is no way to identify patients who will harbor small volume, unilateral prostate cancer at final pathology. implications for focal therapies. Prostate. Jun 1 2012;72(8):925-930. PMID 21965006 Brimo F, Montironi R, Egevad L, et al.(2013) Contemporary grading for prostate cancer: implications for patient care. Eur Urol. May 2013;63(5):892-901. PMID 23092544 Chao B, Lepor H.(2021) 5-Year Outcomes Following Focal Laser Ablation of Prostate Cancer. Urology. Jun 04 2021. PMID 34090887 Crawford ED, Rove KO, Barqawi AB, et al.(2013) Clinical-pathologic correlation between transperineal mapping biopsies of the prostate and three-dimensional reconstruction of prostatectomy specimens. Prostate. May 2013;73(7):778-787. PMID 23169245 Dall'Era MA, Cooperberg MR, Chan JM, et al.(2008) Active surveillance for early-stage prostate cancer: review of the current literature. Cancer. Apr 15 2008;112(8):1650-1659. PMID 18306379 Dickinson L, Ahmed HU, Allen C, et al.(2011) Magnetic resonance imaging for the detection, localisation, and characterisation of prostate cancer: recommendations from a European consensus meeting. Eur Urol. Apr 2011;59(4):477-494. PMID 21195536 Duwe G, Boehm K, Haack M, et al.(2023) Single-center, prospective phase 2 trial of high-intensity focused ultrasound (HIFU) in patients with unilateral localized prostate cancer: good functional results but oncologically not as safe as expected. World J Urol. May 2023; 41(5): 1293-1299. PMID 36920492 Eastham JA, Auffenberg GB, Barocas DA, et al.(2022) Clinically Localized Prostate Cancer: AUA/ASTRO Guideline. 2022; https://www.auanet.org/guidelines/guidelines/clinically-localized-prostate-cancer-aua/astro-guideline-2022. Accessed August 1, 2022. Eastham JA, Kattan MW, Fearn P, et al.(2008) Local progression among men with conservatively treated localized prostate cancer: results from the Transatlantic Prostate Group. Eur Urol. Feb 2008;53(2):347-354. PMID 17544572 Emberton M.(2016) TOOKAD (Padeliporfin) Vascular-Targeted Photodynamic Therapy Versus Active Surveillance in Men With Low Risk Prostate Cancer. . A Randomized Phase 3 Clinical Trial (Abstract LBA02). Paper presented at: 31st Annual European Association of Urology Congress; 2016, March 13; Munich, Germany. Eylert MF, Persad R.(2012) Management of prostate cancer. Br J Hosp Med (Lond). Feb 2012;73(2):95-99. PMID 22504752 Freedland SJ.(2011) Screening, risk assessment, and the approach to therapy in patients with prostate cancer. Cancer. Mar 15 2011;117(6):1123-1135. PMID 20960523 Gallina A, Maccagnano C, Suardi N, et al.(2012) Unilateral positive biopsies in low risk prostate cancer patients diagnosed with extended transrectal ultrasound-guided biopsy schemes do not predict unilateral prostate cancer at radical prostatectomy. BJU Int. Jul 2012;110(2 Pt 2):E64-68. PMID 22093108 Guo CC, Wang Y, Xiao L, et al.(2012) The relationship of TMPRSS2-ERG gene fusion between primary and metastatic prostate cancers. Hum Pathol. May 2012;43(5):644-649. PMID 21937078 Hand L.(2015) FDA Panel Pans HIFU for Prostate Cancer. Jul 31, 2014. Medscape Medical News 2014, WebMD, LLC http://www.medscape.com/viewarticle/829179. Accessed March, 2015. Harnden P, Naylor B, Shelley MD, et al.(2008) The clinical management of patients with a small volume of prostatic cancer on biopsy: what are the risks of progression? A systematic review and meta-analysis. Cancer. Mar 1 2008;112(5):971-981. PMID 18186496 Heidenreich A, Bastian, PJ, Bellmunt, J, et al.(2015) European Association of Urology 2012 guidelines on prostate cancer (available at: http//www.uroweb.org/guidelines/online-guidelines/) Accessed March 30, 2015. Hopstaken JS, Bomers JGR, Sedelaar MJP, et al.(2022) An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years?. Eur Urol. Jan 2022; 81(1): 5-33. PMID 34489140 Hu Y, Ahmed HU, Carter T, et al.(2012) A biopsy simulation study to assess the accuracy of several transrecta ultrasonography (TRUS)-biopsy strategies compared with template prostate mapping biopsies in patients who have undergone radical prostatectomy. BJU Int. Sep 2012;110(6):812-820. PMID 22394583 Iberti CT, Mohamed N, Palese MA.(2011) A review of focal therapy techniques in prostate cancer: clinical results for high-intensity focused ultrasound and focal cryoablation. Rev Urol. 2011;13(4):e196-202. PMID 22232569 Ip S, IJ D, Chung M ea.(2011) An evidence review of active surveillance in men with localized prostate cancer. Evidence Report/Technology Assessment no. 204 HHSA 290-2007-10055-I). 2011;AHRQ Publication No. 12-E003-EF, Rockville, MD: Agency for Research and Quality.(Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.). PMID Jacome-Pita F, Sanchez-Salas R, Barret E, et al.(2014) Focal therapy in prostate cancer: the current situation. Ecancermedicalscience. 2014;8:435. PMID 24944577 Johansson JE, Andren O, Andersson SO, et al.(2004) Natural history of early, localized prostate cancer. JAMA. Jun 9 2004;291(22):2713-2719. PMID 15187052 Kasivisvanathan V, Emberton M, Ahmed HU.(2013) Focal therapy for prostate cancer: rationale and treatment opportunities. Clin Oncol (R Coll Radiol). Aug 2013;25(8):461-473. PMID 23759249 Lecornet E, Ahmed HU, Moore CM, et al.(2010) Conceptual basis for focal therapy in prostate cancer. J Endourol. May 2010;24(5):811-818. PMID 20443699 Lee S, Kim KB, Jo JK, et al.(2015) Prognostic Value of Focal Positive Surgical Margins After Radical Prostatectomy. Clin Genitourin Cancer. 2015 Dec 29. pii: S1558-7673(15)00343-2. Lee T, Mendhiratta N, Sperling D, et al.(2014) Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014;16(2):55-66. PMID 25009445 Lepor H, Llukani E, Sperling D, et al.(2015) Complications, recovery, and early functional outcomes and oncologic control following in-bore focal laser ablation of prostate cancer. Eur Urol. Dec 2015;68(6):924-926. PMID 25979568 Lian H, Zhuang J, Yang R, et al.(2016) Focal cryoablation for unilateral low-intermediate-risk prostate cancer: 63-month mean follow-up results of 41 patients. Int Urol Nephrol. Jan 2016;48(1):85-90. PMID 26531063 Liberati A, Altman DG, Tetzlaff J, et al.(2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. Oct 2009;62(10):e1-34. PMID 19631507 Lindner U, Lawrentschuk N, Schatloff O, et al.(2011) Evolution from active surveillance to focal therapy in the management of prostate cancer. Future Oncol. Jun 2011;7(6):775-787. PMID 21675840 Liu W, Laitinen S, Khan S, et al.(2009) Copy number analysis indicates monoclonal origin of lethal metastatic prostate cancer. Nat Med. May 2009;15(5):559-565. PMID 19363497 Mayes JM, Mouraviev V, Sun L, et al.(2011) Can the conventional sextant prostate biopsy accurately predict unilateral prostate cancer in low-risk, localized, prostate cancer? Urol Oncol. Mar-Apr 2011;29(2):166-170. PMID 19451000 Mehralivand S, George AK, Hoang AN, et al.(2021) MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up. Diagn Interv Radiol. May 2021; 27(3): 394-400. PMID 34003127 Mendez MH, Passoni NM, Pow-Sang J, et al.(2015) Comparison of Outcomes Between Preoperatively Potent Men Treated with Focal Versus Whole Gland Cryotherapy in a Matched Population. J Endourol. Jul 13 2015. PMID 26058496 Mouraviev V, Mayes JM, Madden JF, et al.(2007) Analysis of laterality and percentage of tumor involvement in 1386 prostatectomized specimens for selection of unilateral focal cryotherapy. Technol Cancer Res Treat. Apr 2007;6(2):91-95. PMID 17375971 Mouraviev V, Mayes JM, Polascik TJ.(2009) Pathologic basis of focal therapy for early-stage prostate cancer. Nat Rev Urol. Apr 2009;6(4):205-215. PMID 19352395 Mouraviev V, Mayes JM, Sun L, et al.(2007) Prostate cancer laterality as a rationale of focal ablative therapy for the treatment of clinically localized prostate cancer. Cancer. Aug 15 2007;110(4):906-910. PMID 17587207 Mouraviev V, Villers A, Bostwick DG, et al.(2011) Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int. Oct 2011;108(7):1074-1085. PMID 21489116 Muto S, Yoshii T, Saito K, et al.(2008) Focal therapy with high-intensity-focused ultrasound in the treatment of localized prostate cancer. Jpn J Clin Oncol. Mar 2008;38(3):192-199. PMID 18281309 Nahar B, Bhat A, Reis IM, et al.(2020) Prospective Evaluation of Focal High Intensity Focused Ultrasound for Localized Prostate Cancer. J Urol. Sep 2020; 204(3): 483-489. PMID 32167866 Natarajan S, Raman S, Priester AM, et al.(2016) Focal laser ablation of prostate cancer: phase I clinical trial. J Urol. Jul 2016;196(1):68-75. PMID 26748164 National Comprehensive Cancer Network (NCCN).(2016) NCCN Clinical Practice Guidelines in Oncology: prostate cancer. Version 3.2016. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed August 8, 2016. National Comprehensive Cancer Network (NCCN).(2019) NCCN Clinical Practice Guidelines in Oncology: prostate cancer. Version 2.2019. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed July 20, 2019. National Comprehensive Cancer Network (NCCN).(2021) NCCN Clinical Practice Guidelines in Oncology: prostate cancer. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed July 28, 2021. National Institue for Health and Care Excellence (NICE).(2015) Focal Therapy Using Cryoablation for Localised Prostate Cancer (IPG423). 2012; https://www.nice.org.uk/guidance/ipg423/chapter/1-guidance. Accessed March, 2015. National Institue for Health and Care Excellence (NICE).(2015) Focal Therapy Using High-Intensity Focused Ultrasound for Localized Prostate Cancer (IPG424). 2012; http://www.nice.org.uk/guidance/ipg424. Accessed Mach, 2015. Nelson BA, Shappell SB, Chang SS, et al.(2006) Tumour volume is an independent predictor of prostate-specific antigen recurrence in patients undergoing radical prostatectomy for clinically localized prostate cancer. BJU Int. Jun 2006;97(6):1169-1172. PMID 16686706 Nguyen CT, Jones JS.(2011) Focal therapy in the management of localized prostate cancer. BJU Int. May 2011;107(9):1362-1368. PMID 21223478 Passoni NM, Polascik TJ.(2014) How to select the right patients for focal therapy of prostate cancer? Curr Opin Urol. May 2014;24(3):203-208. PMID 24625428 Ploussard G, Epstein JI, Montironi R, et al.(2011) The contemporary concept of significant versus insignificant prostate cancer. Eur Urol. Aug 2011;60(2):291-303. PMID 21601982 Reddy D, Peters M, Shah TT, et al.(2022) Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience. Eur Urol. Apr 2022; 81(4): 407-413. PMID 35123819 Roach M, 3rd, Hanks G, Thames H, Jr., et al.(2015) Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. Jul 15 2006;65(4):965-974. PMID 16798415 Sanda MG, Chen RC, Crispino T, et al.(2017) Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. http://www.auanet.org/guidelines/clinically-localized-prostate-cancer-new-(aua/astro/suo-guideline-2017). Accessed August 30, 2017. Scales CD, Jr., Presti JC, Jr., Kane CJ, et al.(2007) Predicting unilateral prostate cancer based on biopsy features: implications for focal ablative therapy--results from the SEARCH database. J Urol. Oct 2007;178(4 Pt 1):1249-1252. PMID 17698131 Sinnott M, Falzarano SM, Hernandez AV, et al.(2012) Discrepancy in prostate cancer localization between biopsy and prostatectomy specimens in patients with unilateral positive biopsy: implications for focal therapy. Prostate. Aug 1 2012;72(11):1179-1186. PMID 22161896 Stamey TA, Freiha FS, McNeal JE, et al.(1993) Localized prostate cancer. Relationship of tumor volume to clinical significance for treatment of prostate cancer Cancer. Feb 1 1993;71(3 Suppl):933-938. PMID 7679045 Taneja SS, Bennett J, Coleman J, et al.(2016) Final results of a phase I/II multicenter trial of WST11 vascular targeted photodynamic therapy for hemi-ablation of the prostate in men with unilateral low risk prostate cancer performed in the United States. J Urol. Jun 9 2016. PMID 27291652 Tay KJ, Mendez M, Moul JW, et al.(2015) Active surveillance for prostate cancer: can we modernize contemporary protocols to improve patient selection and outcomes in the focal therapy era? Curr Opin Urol. Mar 12 2015. PMID 25768694 Thompson I, Thrasher JB, Aus G ea.(2007) American Urological Association guideline for management of clinically localized prostate cancer: 2007 update. 2007; http://www.auanet.org/common/pdf/education/clinical-guidance/Prostate-Cancer.pdf. Thompson IM, Jr., Goodman PJ, Tangen CM, et al.(2013) Long-term survival of participants in the prostate cancer prevention trial. N Engl J Med. Aug 15 2013;369(7):603-610. PMID 23944298 Tsivian M, Abern MR, Qi P, et al.(2013) Short-term functional outcomes and complications associated with transperineal template prostate mapping biopsy. Urology. Jul 2013;82(1):166-170. PMID 23697794 Valerio M, Ahmed HU, Emberton M, et al. (2014) The role of focal therapy in the management of localised prostate cancer: a systematic review. Eur Urol. Oct 2014;66(4):732-751. PMID 23769825 van den Bos W, Muller BG, Ahmed H, et al.(2014) Focal therapy in prostate cancer: international multidisciplinary consensus on trial design. Eur Urol. Jun 2014;65(6):1078-1083. PMID 24444476 Ward JF, Jones JS.(2012) Focal cryotherapy for localized prostate cancer: a report from the national Cryo On-Line Database (COLD) Registry. BJU Int. Jun 2012;109(11):1648-1654. PMID 22035200 Whitson JM, Carroll PR.(2010) Active surveillance for early-stage prostate cancer: defining the triggers for intervention. J Clin Oncol. Jun 10 2010;28(17):2807-2809. PMID 20439633 |
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