PSMA PET Registry (18F-DCFPyL)

NCT03535831 | Completed

• 1 other identifier: 17-6021
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 18F-DCFPyL PET changes the detection of lymph node and distant metastases

  To determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether 18F-DCFPyL PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).

  Through study completion up to 5 years

Study Arms (1)

18F-DCFPyL PET/ MR or PET/CT imaging

EXPERIMENTAL

Will use a newer technology called PET-MR that combines a Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. This new combined imaging test, where PET and MRI data is gathered at one time, will be performed on an integrated PET-MR scanner located at Toronto General Hospital. Or technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre. 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.

Diagnostic Test: 18F-DCFPyL

Interventions

18F-DCFPyL DIAGNOSTIC_TEST

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.

18F-DCFPyL PET/ MR or PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologic diagnosis of carcinoma of prostate
• Being staged or restaged for any of the following indications:
• A. Staging of patients with:
• i. 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.
• B. Staging or restaging of PCa with equivocal findings on conventional workup:
• i. 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.
• C. Restaging of patients with:
• i. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Mirshahvalad SA, Basso Dias A, Ortega C, Abreu Gomez JA, Krishna S, Perlis N, Berlin A, van der Kwast T, Jhaveri K, Ghai S, Metser U, Santiago AT, Veit-Haibach P. [18F]F-DCFPyL PET/MRI radiomics for intraprostatic prostate cancer detection and metastases prediction using whole-gland segmentation. Br J Radiol. 2025 Oct 1;98(1174):1606-1614. doi: 10.1093/bjr/tqaf014.

  PMID: 39847533 DERIVED

• Basso Dias A, Finelli A, Bauman G, Veit-Haibach P, Berlin A, Ortega C, Avery L, Metser U. Impact of 18F-DCFPyL PET on Staging and Treatment of Unfavorable Intermediate or High-Risk Prostate Cancer. Radiology. 2022 Sep;304(3):600-608. doi: 10.1148/radiol.211836. Epub 2022 May 24.

  PMID: 35608445 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm study to assess the contribution of 18F-DCFPyL PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 24, 2018
• Study Start: April 27, 2018
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CA (1)