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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02397408

Run by

University of California, San Francisco

People needed

18

Starts

2015-04-09

Expected to finish

2015-06-30

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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