A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Lawson Health Research Institute
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Frequency in change of clinical management based on results of 18F-FCH PET/MRI
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Frequency in change of clinical management based on results of 18F-FCH PET/MRI
Time Frame: Within 2 weeks of study scan
A questionnaire to assess the planned management will be completed by the investigator before and after provision of the results of the 18F-FCH PET/MRI to determine if the information provided by 18F-FCH PET/MRI influences the preferred plan of management
Secondary Outcomes
- Number of lesions identified with 18F-FCH based on consensus reporting(Within 2 weeks of study scan)