| Coverage Policy Manual | |
| Policy #: | 2018017 |
| Category: | Medicine |
| Initiated: | April 2018 |
| Last Review: | September 2023 |
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| Hydrogel Implant for Prostate Radiation Therapy-Absorbable Perirectal Spacer (APS); SpaceOAR System (Augmenix inc) | |
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| Description: |
Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors unlikely to be life-threatening to aggressive tumors that can metastasize, leading to morbidity or death. It is the second most common cancer in men, with over 1 in 10 men diagnosed with prostate cancer over their lifetime. Cancer is typically suspected due to increased levels of prostate-specific antigen upon screening. A digital rectal exam may detect nodules, induration, or asymmetry, which is then followed by an ultrasound-guided biopsy with an evaluation of the number and grade of positive biopsy cores.
Clinical staging is based on the digital rectal exam and biopsy results. T1 lesions are not palpable while T2 lesions are palpable but appear to be confined to the prostate. T3 lesions extend through the prostatic capsule, and T4 lesions are fixed to or invade adjacent structures. The most widely used grading scheme for a prostate biopsy is the Gleason system (Gleason, 1966). It is an architectural grading system ranging from 1 (well-differentiated) to 5 (poorly differentiated); the score is the sum of the primary and secondary patterns. A Gleason score of 6 or less is low-grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-grade cancer that grows more quickly. A revised prostate cancer grading system has been adopted by the National Cancer Institute and the World Health Organization (SEER Database, 2022). A cross-walk of these grading systems is included below.
Prostate Cancer Grading Systems:
Grade Group 1 - Gleason Score 6 or less – Cells: Well-differentiated (low grade)
Grade Group 2 - Gleason Score (Primary and Secondary Pattern) 7 (3 + 4) – Cells: Moderately differentiated (moderate grade)
Grade Group 3 - Gleason Score (Primary and Secondary Pattern)7 (4 + 3) – Cells: Poorly differentiated (high grade)
Grade Group 4 - Gleason Score 8 – Cells: Undifferentiated (high grade)
Grade Group 5 - Gleason Score 9-10 – Cells: Undifferentiated (high grade)
Because the anterior wall of the rectum abuts the posterior prostate, radiotherapy for prostate cancer exposes that portion of the rectum to the full dose of radiation delivered to the prostate, which poses the risk of rectal bleeding for months to years after treatment. Modern radiation planning techniques, such as intensity modulated radiation therapy (IMRT), allow significantly higher doses of radiation to be safely delivered to the prostate while maintaining an acceptable risk of late rectal complications by limiting the portion of the rectum treated to full dose. In recent years, attempts to reduce rectal toxicity have focused on increasing the physical distance between the prostate and rectum by injection of a biodegradable hydrogel to push the rectum away from the high dose region to allow additional dose sparing. The use of an implanted hydrogel spacer between the prostate and rectum has been studied as a way to minimize rectal symptoms during and after definitive radiotherapy for adenocarcinoma of the prostate.
External beam radiation therapy (RT) is a standard treatment option for clinically localized prostate cancer, most commonly delivered using image-guided conformal radiation therapy (CRT), stereotactic body radiotherapy (SBRT), or intensity-modulated (IMRT) and image-guided RT (IGRT). The evidence supporting dose escalation in prostate cancer is well-established, with improved biochemical outcomes, local control, and disease-free survival with doses above 70 grays (Gy).
Rectal toxicity, however, is a major concern with external RT; the rectum is considered to be an organ at risk (OAR). Since the prostate gland sits in front of the rectum, any RT directed at the prostate puts the rectum at risk of radiation exposure. Studies have shown that depending on the dose, volume of radiation, and the type of RT, the rectum can be compromised, with some reports of grade II and higher gastrointestinal (GI) toxicity at 20% to 30% in patients undergoing RT for prostate cancer. Creation of a safety space margin of 4 to 10 millimeters (mm) between the prostate and rectum is purported to decrease the risk of rectal toxicity during prostate RT.
The absorbable perirectal spacer, (APS) (SpaceOAR: Augmenix Inc) intended for use in men undergoing RT for localized prostate cancer, is a polyethylene glycol hydrogel that is injected under anesthesia with transrectal ultrasound guidance into a space between the prostate and rectum. The APS is injected via dual syringes attached to a Y-connector to allow for the 2 precursor agents to mix while being injected. It then polymerizes into a solid spacer within 10 seconds following injection and is said to maintain its structure for 3 months before it starts to slowly hydrolyze and is cleared from the body via the kidneys, with only traces remaining by 6 months (Ruciński, 2013; NIHR, 2014; Pinkawa, 2015; Augmenix, 2016a).
Clinical alternatives to using a hydrogel spacer such as the APS include an inflatable balloon, human collagen, or hyaluronic acid to create a protective space and potentially reduce radiation to the rectum (Prada, 2007; Pinkawa, 2015).
Disease Risk Definitions (Adapted from NCCN 2021 guidelines)
*Low risk of recurrence (ALL must be present to qualify as low risk)
**Intermediate risk of recurrence (ANY one characteristic)
High risk of recurrence (ANY one characteristic)
Localized disease (BOTH must apply)
Locally advanced disease (EITHER must apply)
Coding
The American Medical Association (AMA) established a new Current Procedural Terminology (CPT®) code, 55874, for periprostatic implantation of biodegradable material, under which SpaceOAR hydrogel will be typically billed. The code, was effective January 1, 2018.
55874- Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed
Regulatory
Food and Drug Administration (FDA)
In October 2014, SpaceOAR® (Augmenix, a subsidiary of Boston Scientific) was cleared by the U.S. Food and Drug Administration (FDA) through the De Novo process (DEN140030). SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum."
DuraSeal® Exact (Integra) was approved by the FDA through the premarket approval process as a spine and cranial sealant (dura mater) and has been used off-label as a perirectal spacer.
Safety Concerns
Possible complications include pain associated with the APS injection; pain/discomfort associated with the hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection into the bladder, prostate, rectum, or urethra; local inflammation; infection; injection of air, fluid, or hydrogel intravascularly; urinary retention; rectal mucosal damage; ulcers; necrosis; bleeding; constipation; and rectal urgency (Augmenix, 2016a).
Contraindications
There are no listed contraindications to APS use (Augmenix, 2016a). However, a consensus statement with manufacturer involvement (Müller, 2016) listed the following absolute exclusion criteria: locally advanced prostate cancer or active bleeding disorder. The following relative exclusion criteria were listed: active inflammatory or infectious disease in the perineum or injection area, or prior treatment of the prostate with a high risk of adhesions.
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Policy/ Coverage: |
EFFECTIVE 01/01/2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Transperineal placement of biodegradable material (eg. hydrogel spacer), peri-prostatic, single or multiple injection(s), including image guidance, when performed meets member benefit certificate primary coverage criteria that there be scientific effectiveness when primary definitive radiation therapy will be used to treat low risk* or intermediate risk** prostate cancer (See Description for risk definitions) using EITHER of the following techniques:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for any other circumstance that is not listed above.
For members with contracts without primary coverage criteria, transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance is considered investigational for any other circumstance that is not listed above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to 01/01/2022
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy was developed in response to a request. A complete literature search was conducted and identified 5 clinical studies that evaluated the efficacy and safety of the APS used in the treatment of patients with prostate cancer. Although the clinical significance of dose protection was not always clear, the evidence suggests that the APS in patients undergoing RT to treat prostate cancer can reduce rectal RT exposure. The surrogate outcome of the rectal volume exposed to radiation was the predominant focus of the studies. Reductions in rectal dose have not been shown to translate into convincing clinically significant reductions in rectal toxicity or improvement in quality of life.
The main findings from the identified 5 clinical studies include:
The results of the 5 clinical studies are summarized below.
A very-poor-quality prospective matched-pair analysis study (Pinkawa, 2012) compared the use of the APS during IMRT in men with T1-T3 N0M0 prostate cancer (n=84), IMRT without APS, or 3DCRT without APS. Interpretation of the results is limited by a lack of statistical comparisons between groups. It appears as though at 2 to 3 months follow-up, QOL scores did not differ greatly from baseline scores. Specifically, the results suggest that the spacer resulted in numerically less RT delivered to the rectum. Patients in the APS group reported no statistically significant differences from baseline in any domain of the EPIC QOL scale. However, a clinically meaningful improvement was seen in sexual function (mean change of 5 points) and sexual bother (mean change of 11 points). While statistical comparisons between groups were not made, patients in the 3DCRT group and IMRT group experienced clinically meaningful and statistically significant improvements in bowel bother, sexual function, and sexual bother score. Patients in the IMRT group also experienced improvements in the urinary function and bother domains. Evaluations of specific bowel symptoms demonstrated that 25% of patients receiving the APS reported rectal urgency at least once a day compared with 19% in the 3DCRT group and 11% in the IMRT group. However, no APS patients reported any other bowel symptoms, whereas patients in the 3DCRT and IMRT groups, respectively, reported water bowel movements (11%; 11%); painful bowel movements (15%; 7%); or abdominal, pelvic, or rectal pain (11%; 4%). Study limitations include lack of randomization, small sample size, lack of statistical analyses for comparisons of interest, noncontemporaneous controls, higher prostate volume in the spacer group, high potential for selection bias, censored data, no power analysis, and limited follow-up. Of note, there was a statistically significantly higher RT dose (P<0.01) in the APS group. There is possible patient overlap with Pinkawa, et al (Pinkawa, 2016).
A fair-quality multicenter RCT compared the use of APS with no APS during image-guided IMRT for prostate cancer (n=222) (Mariados, 2015; Pieczonka, 2016). The primary efficacy results suggest that use of the APS was associated with > 25% reduction in the rV70 radiation in most (97.3%) patients. Differences in the primary safety endpoint of grade ≥ 1 rectal or procedural AEs in the APS group versus the control group during the first 6 months were not statistically significant (P=0.7). Incidences of late rectal toxicity (P=0.044) and rectal pain (P=0.022) during and after IMRT were statistically significantly fewer in the APS group compared with controls. Patients treated with the APS did not appear to report statistically or clinically significant deterioration in bowel QOL at 15 months compared with controls. In addition statistically significantly fewer patients treated with APS reported clinically meaningful deterioration in urinary QOL at 6 months compared with controls (P=0.003). Differences at 15 months were not statistically significant. Study limitations include limited follow-up.
A very-poor-quality prospective cohort study compared the APS with a balloon spacer or a control group receiving no spacer (Wolf, 2015) in patients treated with IMRT for the treatment of prostate cancer (n=78). The study suggests that both the hydrogel and balloon spacers reduced the estimated rectal dose significantly relative to the control group; 38% and 63%, respectively (P≤0.001), with the balloon demonstrating an advantage (P=0.035). There were no statistically significant differences in acute grade 1 GI or grade 2 GU toxicity at 90 days after the completion of IMRT. Study limitations include the nonrandomized study design, limited follow-up, small sample size, high potential for selection bias, no power analysis, and lack of reporting of baseline characteristics.
A poor-quality prospective cohort study compared the APS with no spacer (Pinkawa, 2016) in low- to intermediate- and selected high-risk prostate cancer patients treated with 5-field IMRT or VMAT (n=167). The results suggest that the APS resulted in a statistically significantly more favorable bowel function QOL > 1 year after RT (P<0.01); however, a 5 point difference as was demonstrated is considered to indicate little clinical change. Some bowel symptoms > 1 year after RT were favored in the APS group, including loose or liquid stools, bloody stools, painful bowel movements, and increased number of daily bowel movements. No differences were noted among the other bowel symptoms. Statistically significantly fewer patients in the APS group reported moderate or big problems with bowel symptoms. The control group reported statistically significantly more medical interventions (medications) and endoscopic examinations. Study limitations included the lack of randomization, the use of subjective data, patient-reported interventions, and potential for selection bias. Of note, significantly higher percentages of patients with a spacer received doses of 78 to 80 Gy (P<0.01). There is a potential for patient overlap with Pinkawa et al (Pinkawa, 2012).
A poor-quality prospective cohort study compared the APS with no spacer in predominantly T1c-T2 prostate cancer patients (n=140) undergoing image-guided IMRT or VMAT (Whalley, 2016). Rectal dosimetry was statistically significantly reduced with use of the spacer (P<0.01). Postoperative toxicity was mild and did not persist beyond 1 week. Late grade 1 GI toxicity was statistically significantly reduced in the APS group compared with controls (P=0.04). There were no statistically significant differences in the incidence of acute grade 1 or 2 or late grade 2 GI toxicities. Study limitations include the nonrandomized study design, small sample size, lack of power analysis, lack of blinding, and limited follow-up.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through March 2020. There was no new information 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 March 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Miller reported a manufacturer-sponsored meta-analysis that included 6 studies plus 2 additional prospective cohort studies, and 2 retrospective comparative studies on SpaceOAR for brachytherapy (Miller, 2020). The percentage of rectal radiation over 70 Gy was 3.5% with SpaceOAR compared to 10.4% in controls (mean difference, −6.5%; 95%CI, –10.5%to –2.5%; P =.001). The spacer did not reduce the risk of early grade 2 or greater rectal toxicity, but was associated in this analysis with a reduced risk of late grade 2 or higher rectal toxicity (1.5% vs 5.7%; risk ratio, 0.23; 95% CI, 0.06-0.99; P =.05).
Seymour et al published 5-yr QOL outcomes from a combined data set that included patients in the studies by Mariados et al and Pinkawa et al (Seymour, 2020; Mariados, 2015; Pinkawa, 2017). Out of 125 patients from the RCT by Mariados and 165 non-randomized patients from Pinkawa (64% with the spacer and 36% without) there were 199 men who had prospective QOL data (EPIC) with at least 24 month follow-up (median 39.5 months, range 31–71.4). With a prespecified clinically important decline in EPIC of at least 5 points, controls had a decline of 5.1 points compared to an increase of 0.3 points in the spacer group (difference = 5.4, P<.001). A lower percentage of patients had a decline in bowel related QOL of at least 5 points (14% vs 36%, P=.01) and 10 points (6% vs 19%, P=.008). Out of 13 questions, 4 were significantly impaired for bowel function (urgency, loose stools) and bother (urgency, frequency) at 36 months. Limitations of the long-term follow-up remain the same as in the original RCT, since the patients were no longer blinded to treatment and there was high loss to follow-up (47%).
Several retrospective comparative studies have been published that evaluated the effect of a hydrogel spacer on rectal toxicity and quality of life in men who are treated with brachytherapy and EBRT for prostate cancer (Chao, 2019; Kahn, 2020; Nehlsen, 2020). The studies are consistent in showing a decrease in rectal dose with insertion of a hydrogel spacer, with no adverse effect on the dose to the prostate. No study has demonstrated a benefit of a hydrogel spacer on late rectal toxicity or quality of life in these patients. Investigators have noted that there may be some instances where the brachytherapy beads have migrated close to the rectum that might benefit from a spacer, but this will require further study.
September 2021 Update
A pilot study conducted by Song et al (2013) documented the ability to increase the space between the prostate and rectum to an average of 7.5 mm. The additional space resulted in significant reductions in rectal dose across the range of 10 Gy to 75 Gy. No clinical outcomes were reported. Favorable early gastrointestinal (GI) and genitourinary (GU) toxicity profiles were reported in a phase II study by Uhl (2014), but there was no control group for comparison.
External Beam Radiation Therapy
There is a strong secular trend toward the use of shorter courses of external beam radiation therapy to treat low-risk and intermediate-risk prostate cancer. Multiple randomized controlled trials (RCT) of shorter course radiation, also called hypofractionated radiation, have shown equivalent cure rates to conventionally fractionated radiation but with a higher incidence acute rectal toxicity. Given the higher GI toxicity of this regimen, the use of a hydrogel spacer would be most advantageous in this cohort of patients and has become standard of care in this setting.
Stereotactic Body Radiation Therapy
Stereotactic body radiation therapy (SBRT), also termed ultrahypofractionated radiation therapy is an alternative radiation modality to treat low-risk and intermediate risk prostate cancer. Treatment is given in 5 or fewer daily sessions or fractions. Fried et al (2017) reported on the use of a perirectal hydrogel spacer in association with SBRT. The retrospective report demonstrated significant improvement in rectal and penile bulb dosimetry with the use of the spacer in 66 patients compared to 28 patients who had not undergone spacer placement.
A much larger study by Zelefsky and colleagues (2019) examined outcomes in 551 patients with low-risk and intermediate-risk prostate cancer treated with SBRT. The treatment consisted of 37.5-40 Gy in 5 fractions directed to the prostate and seminal vesicles. About half of the patients (269/551) received a rectal spacer as this became a standard part of the group’s treatment protocol in November 2016. The use of a spacer was associated with a significant reduction in any late GI toxicity (1% with spacer vs 6% without, P = .010). Spacer placement also significantly reduced late GU toxicity (15% for spacer vs 32% without, P < .001).
Brachytherapy
The use of a hydrogel spacer in the setting of low dose rate (LDR) brachytherapy has been reported by Khan et al (2020). Forty patients who underwent perirectal hydrogel injection were compared to 40 patients who had not undergone spacer placement. Some of the patients also received external beam radiation. There was a reduction in rectal toxicity at 1 month, but no difference in toxicity at either one or 2-year follow-up. This finding was similar to a previous report by Taggar et al (2018) comparing toxicity in 74 patients with spacer placement prior to Pd-103 LDR brachytherapy to a similar cohort without spacers. Despite improvements in rectal dosimetry, there was no significant improvement in acute rectal toxicity. Further studies are needed to define the role of hydrogel spacer placement, if any, in the setting of brachytherapy.
Systematic Reviews
A systematic review of the use of a hydrogel spacer to reduce toxicity during and after radiotherapy for prostate cancer was recently published by Armstrong et al. This review is more extensive than previous reviews by Miller et al (2020) and the Canadian Agency for Drugs and Technologies in Health (CADTH; 2018). In addition to the RCT described above, they reviewed 18 additional spacer studies looking at several radiotherapy techniques. Seven of the 18 studies evaluated hydrogel use with conventionally fractionated IMRT. Two studies examined outcomes when used with SBRT, and one looked at spacer use with proton therapy. Most of the other studies included patients treated with combinations of external beam radiation and brachytherapy.
A recent Cochrane review (Hickey, 2019) of interventions to reduce acute and late adverse GI effects of pelvic radiotherapy concluded that “low-certainty evidence on balloon and hydrogel spacers suggests that these interventions for prostate cancer RT may make little or no difference to GI outcomes.”
Toxicity and Risk
A recent commentary published in Lancet Oncology urged caution in the widespread use of the hydrogel spacer given the small, expected benefit and the rising number of reported adverse events associated with the procedure. Despite excellent safety in the small trial, there are a growing number of reports of significant adverse events in real-world use. By examining the FDA Manufacturer and User Facility Device (MAUDE) database, the authors identified 85 reported events. The majority of these could be converted into graded toxicities using Common Terminology Criteria for Adverse Events. Approximately 70% of the events were graded 3, 4, or 5, with about 24% falling into the grade 4 category, including colostomy, anaphylactic events, rectal wall injection, and pulmonary embolism. There was one death. They concluded that critical reflection and careful consideration of the need, toxicity, and benefits of perirectal hydrogel spacer placement should precede any recommendation for its use.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Afkhami Ardekani M, Ghaffari H, Navaser M, et al(2021) Effectiveness of rectal displacement devices in managing prostate motion: a systematic review Strahlenther Onkol 2021;197(2):97-115 Aminsharifi A, Kotamarti S, Silver D, et al(2019) Major complications and adverse events related to the injection of the SpaceOAR hydrogel system before radiotherapy for prostate cancer: J Endourol 2019;33(10):868-71 Armstrong N, Bahl A, Pinkawa M, et al(2021) SpaceOAR hydrogel spacer for reducing radiation toxicity during radiotherapy for prostate cancer a systematic review Urology 2021:[Online ahead of print] Augmenix Inc.(2016) Augmenix announces positive SpaceOAR clinical trial results demonstrating superior outcomes at 3-years. 2016b. Http://www.businesswire.com/news/home/20160927006176/en/Augmenix-Announces-Positive-SpaceOAR%C2%AE-Clinical-Trial-Results. Accessed December 3, 2016. Augmenix Inc.(2016) SpaceOAR® System: Product Code SO-2101: Instructions for Use. 2016a. Http://www.spaceoar.com/assets/LCN-80-2101-001-Rev-B_SpaceOAR-System-10mL-IFU-US.pdf. Accessed November 17, 2016. Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S).(2016) Health Policy Advisory Committee on Technology. Technology Brief. Inert liquid-to-solid gels for prostate-rectum separation during prostate radiation therapy. https://www.health.qld.gov.au/healthpact/docs/updates/WP124_update.pdf. Accessed November 14, 2016. Babayan RK, Steinberg ML, Miller LE. (2020) Re: Aminsharifi et al., Major complications adverse events...SpaceOAR hydrogel system before RT...: (From: Aminsharifi A et al., J Endourol 2019;33:868-871) J Endourol. 2020;34(2):240-1. Carvalho IT, Baccaglini W, Claros OR, et al(2018) Genitourinary and gastrointestinal toxicity among patients with localized prostate cancer treated with conventional versus moderately hypofractionated radiation therapy: Acta Oncol 2018;57(8):1003-10 Center for Devices and Radiological Health (CDRH).(2015) SpaceOAR System [classification order]. Food and Drug Administration [website]. Http://www.accessdata.fda.gov/cdrh_docs/pdf14/den140030.pdf. Accessed November 17, 2016. Centers for Disease Control and Prevention (CDC).(2015) Prostate Cancer Risk by Age. http://www.cdc.gov/cancer/prostate/statistics/age.htm. Accessed November 17, 2016. Centers for Disease Control and Prevention (CDC).(2015) What is Prostate Cancer? http://www.cdc.gov/cancer/prostate/basic_info/what-is-prostate-cancer.htm. Accessed November 17, 2016. Chao M, Ow D, Ho H, et al.(2019) Improving rectal dosimetry for patients with intermediate and high-risk prostate cancer undergoing combined high-dose-rate brachytherapy and external beam radiotherapy with hydrogel space. J Contemp Brachytherapy. Feb 2019; 11(1): 8-13. PMID 30911304 Chao Y, MacDougall D, de Nanassy A, et al. (2019) CADTH rapid response report: summary with critical appraisal. Hydrogel spacers for patients with prostate cancer: (2019) [36 p.]. Available from: https://www.cadth.ca/hydrogel-spacers-patients-prostate-cancer-review-clinical-effectiveness-and-cost-effectiveness. Chodak G.(2015) Perirectal Spacing in Prostate Radiation: Worth the Cost? Medscape from WebMD [website requires free one-time registration]. Available at: http://www.medscape.com/viewarticle/845918. Accessed November 18, 2016. Dearnaley D, Syndikus I, Mossop H, et al(2016) Conventional vs hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial Lancet Oncol 2016;17(8):1047-60 Fransson P, Nilsson P, Gunnlaugsson A, et al(2021) Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial Lancet Oncol 2021;22(2):235-45 Fried DB, Dubose RS, Johnson K, et al(2017) Dosimetry for organs at risk with and without use of perirectal hydrogel spacer in prostate cancer patients treated with sbrt International Journal of Radiation Oncology Biology Physics 2017;99 (2 Supplement 1):E233 Gleason DF.(1966) Classification of prostatic carcinomas. Cancer Chemother Rep. Mar 1966; 50(3): 125-8. PMID 5948714 Hall WA, Tree AC, Dearnaley D, et al(2021) Considering benefit and risk before routinely recommending SpaceOAR Lancet Oncol 2021;22(1):11-3 Hickey BE, James ML, Daly T, et al(2019) Hypofractionation for clinically localized prostate cancer (review) Cochrane Database Syst Rev 2019(9):article number CD011462 Hoffman KE, Voong KR, Levy LB, et al(2018) Randomized trial of hypofractionated, dose-escalated, intensity-modulated radiation therapy (IMRT) vs conventionally fractionated IMRT for localized prostate cancer J Clin Oncol 2018;36(29):2943-9 Hollmer M.(2015) Augmenix wins FDA nod for SpaceOAR prostate treatment. MassDevice [website]. Available at: http://www.massdevice.com/augmenix-wins-fda-nod-spaceoar-prostate-treatment/ Accessed November 1, 2016. Huang EH, Pollack A, Levy L, et al.(2002) Late rectal toxicity: dose-volume effects of conformal radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2002;54(5):1314-1321. Hutchinson RC, Sundaram V, Folkert M, Lotan Y.(2016) Decision analysis model evaluating the cost of a temporary hydrogel rectal spacer before prostate radiation therapy to reduce the incidence of rectal complications. Urol Oncol. 2016;34(7):291.e19-291.e26. Kahn J, Dahman B, McLaughlin C, et al.(2020) Rectal spacing, prostate coverage, and periprocedural outcomes after hydrogel spacer injection during low-dose-rate brachytherapy implantation. Brachytherapy. Mar 2020; 19(2): 228-233. PMID 32085930 Kahn J, Dahman B, McLaughlin C, Kapoor P, Kapoor R, Harris E, Sharma M, Schutzer M, Moghanaki D(2020) Rectal spacing, prostate coverage, and periprocedural outcomes after hydrogel spacer injection during low-dose-rate brachytherapy implantation. Brachytherapy. 2020 Mar-Apr;19(2):228-233. doi: 10.1016/j.brachy.2019.11.002. Epub 2020 Feb 19. PMID: 32085930. Luo C, Yang CC, Narayan S, et al.(2006) Use of benchmark dose volume histograms for selection of the optimal technique between three-dimensional conformal radiation therapy and intensity-modulated radiation therapy in prostate cancer. Int J Radiat Oncol Biol Phys. 2006;66(4):1253-1262. Mariados N, Sylvester J, Shah D, et al.(2015) Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate mage guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015;92(5):971-977. Michalski JM, Yan Y, Watkins-Bruner D, et al.(2013) Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013;87(5):932-938. Miller L, Efstathiou J, Bhattacharyya S, Payne H, et al.(2020) Association of the Placement of a Perirectal Hydrogel Spacer With the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020;3(6):e208221. doi:10.1001/jamanetworkopen.2020.8221 Miller LE, Efstathiou JA, Bhattacharyya SK, et al.(2020) Association of the placement of a perirectal hydrogel spacer with the clinical outcomes of men receiving radiotherapy for prostate cancer: a systematic review and meta-analysis. JAMA netw. 2020;3(6):e208221. Mulcahy N.(2016) 'Good tool': Hydrogel Spares Rectum From Radiation: 3-Year Data Show Durable Safety Effect. Medscape Medical News from WebMD [website requires free one-time registration]. Available at: http://www.medscape.com/viewarticle/869398. 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