PSMA-PET Registry for Recurrent Prostate Cancer

Phase 2

Inclusion Criteria:

1. Written informed consent obtained
2. Male, Age ≥ 18 years
3. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort 7.
4. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):

   1. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (\>0.1ng/ml) within 3 months post-surgery
   2. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:

   i. Following primary radical prostatectomy, BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured at \>0.1 ng/ml

   ii. Following primary radiotherapy for localized disease, BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured greater than the nadir PSA + 2.0 ng/ml
5. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.
6. Karnofsky performance status 70 or better (ECOG 0, 1).
7. If PSA \>10 mg/mL, conventional imaging consisting of bone scan and abdo-pelvic CT scan within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified).

Exclusion Criteria:

1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
2. Prior PSMA PET scan within 6 months of enrollment.
3. Patient cannot lie still for at least 60 minutes or comply with imaging.
4. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

Phase 3

Inclusion Criteria:

1. Written informed consent obtained
2. Male, Age ≥ 18 years
3. Biopsy proven, clinically high risk (cT3, PSA ≥20, biopsy Gleason Grade Group 4-5) prostate cancer undergoing initial staging prior to primary treatment with surgery or radiotherapy

   OR

   Biochemical failure (BF) with current management defined as at least two consecutive rises in PSA measured at least 1 month apart with the most recent PSA level \>0.1 ng/ml (post radical prostatectomy or post PSMA Directed therapy, Cohorts 1-5) or PSA level \> nadir PSA + 2.0 ng/ml (Phoenix definition post radiotherapy failure, Cohorts 5, 6)

   OR

   Men with rising PSA and/or progression on conventional imaging despite prior second line hormone therapy or chemotherapy for castrate resistant prostate cancer (Cohort 8).

   OR

   PET/CT requested as part of Cohort 7.
4. Patient scenario falls into one of the 8 pre-defined cohorts. When patient scenario falls outside cohorts 0-6 and 8, participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.
5. Karnofsky performance status 70 or better (ECOG 0, 1)
6. If recurrent disease suspected and PSA prior to PSMA PET/CT is \>10 ng/ml, conventional imaging consisting of bone scan and abdominal-pelvic CT scan performed within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified). Registration is defined as Form A: Eligibility is complete.
7. If patient is enrolled in Cohort 8, conventional imaging consisting of at least bone scan and abdominal-pelvic CT scan completed within 3 months of registration. Registration is defined as Form A: Eligibility is complete.

Exclusion Criteria:

1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
2. Prior PSMA PET scan within 6 months of enrollment
3. Institution of or change in systemic therapy within 6 weeks prior to PSMA PET/CT request
4. Patient cannot lie still for at least 60 minutes or comply with imaging
5. Patients falling outside of Cohorts 0-6 and 8 where independent adjudication by CCO does not support participation in the Registry