1. Age > 18 y/o and ECOG performance status 0-2, AND
2. Documentation of a PSMA positive PET/CT scan*, AND
3. Documentation of serum testosterone of <50 ng/dL (< 1.7 nmol/L), AND
4. Prior treatment with one or more AR (androgen receptor) pathway inhibitor (e.g. enzalutamide [Xtandi] and/or abiraterone [Zyitga], and/or apalutamide, and/or darolutamide, AND
5. Prior treatment with one but no more than two taxane agents (e.g., cabazitaxel and/or docetaxel), AND
6. No combined concurrent use with immunotherapy or cytotoxic chemotherapy, AND
7. No concurrent use with any investigational agent or another radiotherapy AND
8. Must be dosed in accordance with the FDA label.

 *Note: See coverage policy 2001035, PET or PET/CT for Prostate Cancer, FDG and non-FDG for criteria related to PSMA PET/CT scan.

1. ALL the above criteria are met; AND
2. There is no evidence of disease progression (worsening CT/MRI and/or biomarkers (e.g., PSA) and/or documentation of serious adverse events.

1. Age > 18 y/o and ECOG performance status 0-2, AND
2. Documentation of a PSMA positive PET/CT scan*, AND
3. Documentation of serum testosterone of <50 ng/dL (< 1.7 nmol/L), AND
4. Prior treatment with one or more AR (androgen receptor) pathway inhibitor (e.g. enzalutamide [Xtandi] and/or abiraterone [Zyitga], and/or apalutamide, and/or darolutamide, AND
5. Prior treatment with one but no more than two taxane agents (e.g., cabazitaxel and/or docetaxel), AND
6. No combined concurrent use with immunotherapy or cytotoxic chemotherapy, AND
7. No concurrent use with any investigational agent or another radiotherapy AND
8. Must be dosed in accordance with the FDA label.

1. ALL the above criteria are met; AND
2. There is no evidence of disease progression (worsening CT/MRI and/or biomarkers (e.g., PSA) and/or documentation of serious adverse events.

1. Age > 18 y/o and ECOG performance status 0-2, AND
2. Documentation of a PSMA positive PET/CT scan*, AND
3. Documentation of serum testosterone of <50 ng/dL (< 1.7 nmol/L), AND
4. Prior treatment with one or more AR (androgen receptor) pathway inhibitor (e.g. enzalutamide [Xtandi] and/or abiraterone [Zyitga], and/or apalutamide, and/or darolutamide, AND
5. Prior treatment with one but no more than two taxane agents (e.g., cabazitaxel and/or docetaxel), AND
6. No combined concurrent use with immunotherapy or cytotoxic chemotherapy, AND
7. No concurrent use with any investigational agent or another radiotherapy AND
8. Must be dosed in accordance with the FDA label.

* Either  68Ga Prostate specific membrane antigen (PSMA) -11 [Locametz] PET/CT OR 18F DCFPyL (piflufolastat or Pylarify) PET/CT would be covered for consideration of the use of lutetium (Lu 177) vipivotide tetraxetan for:

 

1. The treatment of documented progressive metastatic castrate resistant prostate cancer (mCRPC) OR
2. For salvage therapy when ALL the below criteria are met:

a. Original clinical stage T1-T3 and NX or N0 treated with prostatectomy and/or radiation therapy, with biochemically recurrent/persistent disease (1).

b. Results of conventional imaging (2) performed within the past 60 days are negative for metastasis

c. Patient is a candidate for curative intent salvage therapy (3)

d. PSA level is > 1 ng/ml or PSA is rising

e. PET/CT has not been performed within the past 3 months

(1) Post-prostatectomy (PSA should be 0 after surgery):

-Persistence: Detection of a PSA higher than 0 within the first three months after surgery;

-Recurrence: PSA initially undetectable, then rising PSA ≥ 0.2 ng/ml, with a second confirmatory level ≥ 0.2 ng/mL (American Urological Association definition)

 Post-radiation therapy:

-Recurrence: rise by ≥ 2 ng/mL above the nadir PSA (Radiation Therapy Oncology Group-American Society of Therapeutic Radiology and Oncology (RTOG-ASTRO) Phoenix Consensus)

(2) Conventional imaging: CT Abdomen and/or Pelvis or MRI pelvis, or mpMRI, or bone scan. Conventional imaging not required for low-risk disease (T1-T2a, PSA < 10 ng/ml, AND Gleason 6).

(3) External beam radiation therapy ± androgen deprivation therapy after prostatectomy OR radical prostatectomy, cryosurgery, high intensity focused ultrasound, or brachytherapy after external beam radiation therapy

1. ALL the above criteria are met; AND
2. There is no evidence of disease progression (worsening CT/MRI and/or biomarkers (e.g., PSA) and/or documentation of serious adverse events.

1. Age > 18 y/o and ECOG performance status 0-2, AND
2. Documentation of a PSMA positive PET/CT scan*, AND
3. Documentation of serum testosterone of <50 ng/dL (< 1.7 nmol/L), AND
4. Prior treatment with one or more AR (androgen receptor) pathway inhibitor (e.g. enzalutamide [Xtandi] and/or abiraterone [Zyitga], and/or apalutamide, and/or darolutamide, AND
5. Prior treatment with one but no more than two taxane agents (e.g., cabazitaxel and/or docetaxel), AND
6. No combined concurrent use with immunotherapy or cytotoxic chemotherapy, AND
7. No concurrent use with any investigational agent or another radiotherapy

1. All of the above criteria are met; AND
2. There is no evidence of disease progression (worsening CT/MRI and/or biomarkers (e.g., PSA) and/or documentation of serious adverse events.

1. Age > 18 y/o and ECOG performance status 0-2, AND
2. Documentation of a Ga-PSMA positive PET/CT scan*, AND
3. Documentation of serum testosterone of <50 ng/dL (< 1.7 nmol/L), AND
4. Prior treatment with one or more AR (androgen receptor) pathway inhibitor (e.g. enzalutamide [Xtandi] and/or abiraterone [Zyitga], and/or apalutamide, and/or darolutamide, AND
5. Prior treatment with one but no more than two taxane agents (e.g., cabazitaxel and/or docetaxel), AND
6. No combined concurrent use with immunotherapy or cytotoxic chemotherapy, AND
7. No concurrent use with any investigational agent or another radiotherapy

1. All of the above criteria are met; AND
2. There is no evidence of disease progression (worsening CT/MRI and/or biomarkers (e.g., PSA) and/or documentation of serious adverse events.

• NCT04689828 (PSMAfore): Phase 3 study comparing 177Lu-PSMA-617 versus androgen receptor-directed therapy in the treatment of progressive mCRPC
• NCT04720157 (PSMAddition): Phase 3 study comparing 177Lu-PSMA-617 in combination with SoC, versus SoC alone, in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC)
• NCT05204927: Phase 3 study comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with mCRPC