This trial is active, not recruiting.

Condition prostate cancer
Treatment 18f-fch pet/mri imaging
Sponsor Lawson Health Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date April 2013
End date January 2017
Trial size 22 participants
Trial identifier NCT01804231, CTP-87515, IGPC-3


Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy.

We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Patients eligible for the study will have an 18F-FCH PET/MRI in addition to standard of care clinical assessment and imaging (CT and bone scan)
18f-fch pet/mri imaging
Patients will first undergo screening to ensure eligibility. If eligible, they will undergo one scan in a Hybrid PET/MRI scanner using 18F-FCH as the radiolabeled tracer.

Primary Outcomes

Frequency in change of clinical management based on results of 18F-FCH PET/MRI
time frame: Within 2 weeks of study scan

Secondary Outcomes

Number of lesions identified with 18F-FCH based on consensus reporting
time frame: Within 2 weeks of study scan

Eligibility Criteria

Male participants from 19 years up to 100 years old.

Inclusion Criteria: - Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy or radiotherapy - Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months apart and an absolute PSA > 0.2 ng/mL - Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease Exclusion Criteria: - Evidence of metastatic disease - Contradiction to 18F-FCH PET scan - Contraindication to MRI

Additional Information

Official title A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
Principal investigator Dr. Glenn S Bauman, MD
Description The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy or radiation with negative bone and CT scans. Hybrid PET/MRI using 18F-FCH will be obtained and a consensus staging report generated for the attending clinician. Clinical management questionnaires completed by the study investigator will be obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical decision making.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.