An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: Male

Summary

This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Histologically or cytologically proven prostate carcinoma

• Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)

• Castration naive disease, no prior systemic therapy for prostate cancer

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

• Ability to understand and willingness to sign informed consent

Exclusion Criteria:

• Known brain metastasis

• Small cell carcinoma of the prostate