Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: 18F-FCH PET/MRI imaging

• Registration Number: NCT01804231
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-05
• Study Start: 2013-07-09
• Primary Completion: 2015-12-15
• Study Completion: 2016-10-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FCH PET/MRI imaging	18F-FCH PET/MRI imaging	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)

Primary Outcome Measures

Name	Time	Method
Frequency in change of clinical management based on results of 18F-FCH PET/MRI	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 Outcome Measures

Name	Time	Method
Number of lesions identified with 18F-FCH based on consensus reporting	Within 2 weeks of study scan

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada