PSMA-PET Registry for Recurrent Prostate Cancer

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Oct 22, 2018

Keywords

ClinConnect Summary

The PSMA-PET Registry for Recurrent Prostate Cancer is a study designed to better understand and treat men with recurring prostate cancer. The researchers want to use a new imaging method called PSMA-PET, which helps identify patterns of cancer recurrence. By gathering information across Ontario, they hope to personalize treatment plans for patients who have already undergone primary treatments like surgery or radiation.

To be eligible for this study, participants should be men aged 18 or older who have previously received treatment for localized prostate cancer and are now suspected to have persistent or recurrent disease. This could be indicated by rising levels of a substance called PSA, which can signal cancer activity. Participants will undergo a PSMA-PET scan, and the study aims to improve their care based on the results. If you or someone you know is considering this trial, it’s important to understand that only certain types of prostate cancer are included, and there are specific criteria that must be met to participate.

Gender

MALE

Eligibility criteria

• • 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.