PSMA-PET Registry for Recurrent Prostate Cancer

Prior treatment

• Prior PSMA PET scan within 6 months of enrollment.
• Prior PSMA PET scan within 6 months of enrollment
• Institution of or change in systemic therapy within 6 weeks prior to PSMA PET/CT request

Other illness

• Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
• Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components

Other

• Patient cannot lie still for at least 60 minutes or comply with imaging.
• Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.
  • Phase 3
• Patient cannot lie still for at least 60 minutes or comply with imaging
• Patients falling outside of Cohorts 0-6 and 8 where independent adjudication by CCO does not support participation in the Registry

• Written informed consent obtained
• Male, Age ≥ 18 years
• 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.
• Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):
  • 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
  • Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
  • 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
  • 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
• 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.
• Karnofsky performance status 70 or better (ECOG 0, 1).
• 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).
• Written informed consent obtained
• Male, Age ≥ 18 years
• 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.
• 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.
• Karnofsky performance status 70 or better (ECOG 0, 1)
• 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.
• 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.

Criteria the registry did not label

• Phase 2