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

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ClinicalTrials.gov Identifier: NCT01804231
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: 18F-FCH PET/MRI imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy
Actual Study Start Date : July 9, 2013
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : October 12, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Other: 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 Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of lesions identified with 18F-FCH based on consensus reporting [ Time Frame: Within 2 weeks of study scan ]

Other Outcome Measures:
  1. Concordance between MRI and 18F-FCH PET for lesion identification [ Time Frame: Within 2 weeks of study scan ]
    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



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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804231


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Dr. Glenn S Bauman, MD London Health Sciences Centre

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01804231     History of Changes
Other Study ID Numbers: IGPC-3
CTP-87515 ( Other Grant/Funding Number: CIHR )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawson Health Research Institute:
Prostate Cancer
PET
MRI
Hybrid
Recurrence
Fluorocholine

Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes