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

NCT02840552 | Completed Phase 3

• 1 other identifier: 16-061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Safety of FCH-PET/CT imaging as measured by the incidence of adverse events (AE)

  7 days

• Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth

  12 months

• Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth

  12 months

Study Arms (1)

FCH-PET/CT

EXPERIMENTAL

18F-Fluoromethylcholine (18F-FCH) PET/CT

Drug: 18F-Fluoromethylcholine (18F-FCH)

Interventions

18F-Fluoromethylcholine (18F-FCH) DRUG

FCH PET/CT

FCH-PET/CT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluoromethylcholine; fluorocholine

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: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

CA (1)