This clinical trial studies how well fluorine F 18 choline (18F-choline) positron emission tomography (PET)/computed tomography (CT) and magnetic resonance imaging (MRI) work compared with biopsy in finding cancer in patients with prostate cancer undergoing biopsy. Diagnostic procedures, such as fluorine F 18-choline PET/CT and MRI, may help doctors find and measure prostate cancer, which may allow them to determine how aggressive the cancer is and whether it needs treatment without needing to perform surgery for a biopsy. It is not yet known whether fluorine F 18-choline PET/CT or MRI works better in finding prostate cancer and whether they are as accurate as biopsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01751737.
PRIMARY OBJECTIVES:
I. Evaluation of the magnitude of uptake and retention of 18F-choline in primary prostate cancer in patients undergoing diagnostic prostate biopsy.
II. Evaluation whether pre‐biopsy MRI can specifically guide prostate biopsies to the most relevant disease.
III. Evaluation of underlying metabolic pathways of choline in primary prostate cancer.
SECONDARY OBJECTIVES:
I. Evaluation of the spatial distribution pattern obtained from 18F‐choline, multi‐sequence MRI and parametric PET/MRI (choline uptake [PCHOL]/apparent diffusion coefficient [ADC]) in comparison with Gleason scores (at three levels) obtained from prostate cancer biopsies.
II. Evaluation of the reproducibility of measurements obtained from 18F‐choline, ADC, and PCHOL/ADC for known prostate cancer lesions over time (between 2 to 4 years).
OUTLINE:
Patients undergo fluorine F 18 choline PET/CT and gadolinium-enhanced MRI. Within 12 weeks of scan, patients undergo prostate biopsy. Patients proceed to either definitive treatment, comprising radiation therapy or prostatectomy, or clinical surveillance. Patients may undergo imaging and biopsy up to 2 times within 4 years.
After completion of each imaging session, patients are followed up at 24 hours.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorMorand Ruediger Piert
