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Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer (IGPC-3)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18F-FCH PET/MRI imaging
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, PET, MRI, Hybrid, Recurrence, Fluorocholine

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

18F-FCH PET/MRI imaging

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of lesions identified with 18F-FCH based on consensus reporting

Full Information

First Posted
February 27, 2013
Last Updated
July 26, 2018
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01804231
Brief Title
Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer
Acronym
IGPC-3
Official Title
A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 9, 2013 (Actual)
Primary Completion Date
December 15, 2015 (Actual)
Study Completion Date
October 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, PET, MRI, Hybrid, Recurrence, Fluorocholine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FCH PET/MRI imaging
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
18F-FCH PET/MRI imaging
Intervention Description
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 Outcome Measure Information:
Title
Frequency in change of clinical management based on results of 18F-FCH PET/MRI
Description
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
Time Frame
Within 2 weeks of study scan
Secondary Outcome Measure Information:
Title
Number of lesions identified with 18F-FCH based on consensus reporting
Time Frame
Within 2 weeks of study scan
Other Pre-specified Outcome Measures:
Title
Concordance between MRI and 18F-FCH PET for lesion identification
Description
Lesions identified on the 18F-FCH MRI/PET will be examined to determine what proportion of lesions are present on both MRI and PET imaging versus what proportion of lesions are present on only one of MRI or PET
Time Frame
Within 2 weeks of study scan

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Glenn S Bauman, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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