The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborator: Montreal Neurological Institute and Hospital
• Treatments: Choline

Criteria

Global Inclusion Criteria:

• Resident of Canada

• 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 completing a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Global 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 who are claustrophobic.

Clinical Indication Criteria Subgroups:

• BCR: Biochemical recurrence as defined by serum PSA > 1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management.

• HRS: Staging of high risk 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 conventional staging such as CT, MRI or bone scan

• Clinical suspicion of advance stage disease (e.g. bone pain)