Clinical Trial · NCT02840552

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT02840552

Eligibility

Inclusion

Male sex
Previously diagnosed with prostate cancer, under referring physician's care
Resident of Canada
ECOG performance status 0 - 3, inclusive
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 injectionGlobal

Exclusion

Patients who are claustrophobic.Clinical Indication Criteria Subgroups:
HRS: Staging of high risk patients as defined by any one of the following:
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)
Serum PSA \> 15 ng/ml
Clinical suspicion of advance stage disease (e.g. bone pain)
T stage of T3 or greater on TNM staging
Equivocal conventional staging such as CT, MRI or bone scan
Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
Gleason score \> 7
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.