68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in patients with prostate cancer undergoing surgery that tend to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Biopsy proven prostate adenocarcinoma

• Planned prostatectomy with lymph node dissection

• Intermediate to high risk disease (as determined by elevated PSA [PSA>10], T stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)

• Able to provide written consent.

• Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent)

• Diagnostic CT or MRI performed within 90 days of the research PET

Exclusion Criteria:

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam

• Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)

• Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery

• Metallic implants (contraindicated for MRI)