Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: 18F-DCFPyL PET/CT

Detailed Description

Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.

Primary endpoint:

1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.

Secondary endpoints:

1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male sex
• Age 18 years or older
• Previously diagnosed with prostate cancer, under referring physician's care
• ECOG performance status 0 - 3, inclusive
• Able to understand and provide written informed consent
• Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:

• Gleason score > 7
• Serum PSA > 15 ng/ml
• T stage of T3 or greater on TNM staging
• Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
• Clinical suspicion of advance stage disease (e.g. bone pain)

Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.

Exclusion Criteria:

• Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
• Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
• Patients with unmanageable claustrophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-DCFPyL PET/CT; 18F-DCFPyL PET/CT Scan	Diagnostic test: 18F-DCFPyL PET/CT; 18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in optimal clinical management	Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scan positivity fraction in BCR by PSA.	18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.	30 days
Adverse events	Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.	2 hours

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No