NCT03535831Completed
PSMA PET Registry (18F-DCFPyL)
Princess Margaret Cancer Centre 18F-DCFPyL PET Registry
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa). Background: Currently, patients with intermediate or high risk prostate cancer are staged with CT abdomen and pelvis and bone scan to assess for distant metastases. Patients with biochemical recurrence after primary therapy are restaged in a similar manner. Locally, multiparametric MR of the prostate or prostate bed may also be obtained in select cases. Patients recruited for this registry will be staged/ restaged with PSMA PET (PET/CT or PET/MR) to determine whether this imaging strategy results in more accurate detection of metastatic disease (for patients undergoing primary staging) or detection of local recurrence or distant disease (for patients undergoing restaging). Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging. Study design: This is a single arm study to assess the contribution of PSMA PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa). In this prospective trial, the investigators will recruit 200 men whom will undergo PET imaging using an integrated PET/CT scanner or with an integrated PET/MR. Patients will receive standard treatment for PCa according to UHN/PMH urology oncology site policies. Treatment outcome including clinical response, blood work including serial serum PSA, and follow-up imaging if performed up to 5 years will be recorded.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 21 Apr 2018
- Start date
- 27 Apr 2018
- Primary completion date
- 3 Oct 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT03535831
What you commit to
- Study type: Interventional
- Participants enrolled: 142
- From 27 Apr 2018 to the primary completion date, 3 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management. In case of uncertainty, the patient will be discussed at multidisciplinary tumor boards and a majority decision will be made
Other
- Patients will be ineligible to participate in this study if they meet any of the following criteria:
- Inability to lie still for PET/CT or PET/MR examination
- For patients undergoing PET/MR only, any contraindication to MRI as per Joint Department of Medical Imaging policies (this exclusion criterion would not exclude patient from enrolling in the registry and undergoing PET/CT).
Who the study is looking for
- Patients will be eligible for inclusion in this study if they meet all of the following criteria:
- Age ≥ 18 years
- Histologic diagnosis of carcinoma of prostate
- Being staged or restaged for any of the following indications:
- Staging of patients with:
- High risk disease; defined as at least one of the following: a. Gleason ≥8, b. ≥T3 disease, c. PSA \>20 ng/ml; ii. Unfavourable intermediate-risk disease defined as: a. more than one intermediate-risk factor (cT2b/ cT2c; GS=7; serum PSA of 10-20 ng/ml); or b. Gleason score of 4+3=7 or more; or c. greater than 50% positive biopsy cores.
- Staging or restaging of PCa with equivocal findings on conventional workup:
- Patients with PCa being staged or restaged with equivocal findings on conventional workup (CT, bone scan, MRI); to help guide management or select appropriate site for biopsy to establish disease status.
- Restaging of patients with:
- Biochemical failure (BCF) after primary therapy (radical prostatectomy or primary radiotherapy), or ii. BCF after salvage therapy/therapies when further treatment is being considered or iii. Pathologically involved nodes at time of radical prostatectomy or iv. Persistently detectable PSA (\>0.1 ng/ml) \>3 months after prostatectomy 5.1.4 Ability to provide written informed consent to participate in the study
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.