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

Lawson Health Research Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: 18F-FCH PET/MRI imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01804231

CTP-87515 (Other Grant/Funding Number)

IGPC-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Male

Ages: 19 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

18F-FCH PET/MRI imaging

Other group

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)

Treatment:

Other: 18F-FCH PET/MRI imaging