Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

• Status: Completed
• Trial end date: 2020-01-23
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Choline

Criteria

Inclusion Criteria:

1. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.

Exclusion Criteria:

1. Patients who already received primary treatment or neo-adjuvant therapy.

2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.

3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]).

4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.

5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.

6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.