Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer
IGPC-3
A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Jul 2013
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedStudy Start
First participant enrolled
July 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2016
CompletedJuly 30, 2018
March 1, 2018
2.4 years
February 27, 2013
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency in change of clinical management based on results of 18F-FCH PET/MRI
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
Within 2 weeks of study scan
Secondary Outcomes (1)
Number of lesions identified with 18F-FCH based on consensus reporting
Within 2 weeks of study scan
Other Outcomes (1)
Concordance between MRI and 18F-FCH PET for lesion identification
Within 2 weeks of study scan
Study Arms (1)
18F-FCH PET/MRI imaging
OTHERPatients 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of metastatic disease
- Contradiction to 18F-FCH PET scan
- Contraindication to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Glenn S Bauman, MD
London Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 5, 2013
Study Start
July 9, 2013
Primary Completion
December 15, 2015
Study Completion
October 12, 2016
Last Updated
July 30, 2018
Record last verified: 2018-03