PSMA-PET Registry for Recurrent Prostate Cancer
Condition: Recurrent Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03718260
Sponsor: Lawson Health Research Institute
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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
- 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: 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
- 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
- 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).
- Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
- Prior PSMA PET scan within 6 months of enrollment.
- 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.
View trial on ClinicalTrials.gov