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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804231
• Other study ID #: IGPC-3
• Secondary ID: CTP-87515
• Status: Completed
• Phase: N/A
• Start date: July 9, 2013
• Est. completion date: October 12, 2016

Study information

• Verified date: March 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 12, 2016
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concordance between MRI and 18F-FCH PET for lesion identification	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	Within 2 weeks of study scan
Primary	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	Number of lesions identified with 18F-FCH based on consensus reporting		Within 2 weeks of study scan