PSMA PET Registry (18F-DCFPyL)
NCT03535831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2026-02-03
Summary
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.
Conditions
- Carcinoma of Prostate
Interventions
- DIAGNOSTIC_TEST
-
18F-DCFPyL
The purpose of this study is to determine if use of 18F-DCFPyL would increase the detection of lesions and to better inform your oncologist on the best method of treatment for your disease.
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-27
- Primary Completion
- 2025-10-03
- Completion
- 2025-10-03
Countries
- Canada
Study Locations
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