11C- and 18F-Choline PET/MR Imaging for Prostate Cancer

• Status: Completed
• Trial end date: 2015-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Choline

Criteria

Inclusion Criteria:

• Age: Patients must be >=18 years of age

• Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.

• Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10)

• Karnofsky Performance Status >=70

• Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan

• Planned to undergo radical prostatectomy and extended pelvic lymph node dissection

• Adequate bone marrow and organ function defined as follows:

• Adequate bone marrow function:

• Leukocytes >= 3,000/microliter (mcL)

• Absolute Neutrophil Count >= 1,500/mcL

• Platelets >= 100,000/mcL

• Adequate hepatic function:

• Total bilirubin - within normal institutional limits

• Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) <= 2.5 X institutional upper limit of normal

• Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <= 2.5 X institutional upper limit of normal

• Adequate renal function:

• Creatinine - within normal institutional limits OR

• Creatinine clearance >= 60 mL/min/ 1.73m2 for patients with creatinine levels above institutional normal

• Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

• Participation would significantly delay the scheduled standard of care therapy

• Karnofsky performance status of < 60

• Inadequate venous access

• Administered a radioisotope within 5 physical half lives prior to study enrollment

• Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.