Choline PET/CT and MRI for Targeted Prostate Biopsy
This is an explorative diagnostic basic research study to assess the value of 18F-choline PET/CT and multi-sequence MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients will receive image-guided (targeted) prostate biopsies and metabolomic profiling of prostate biopsy tissues to evaluate underlying metabolic changes in comparison with pathological Gleason grading.
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Investigation of the Magnitude of Uptake, Retention, and Spatial Distribution Pattern of 18F-Choline in Comparison With MRI and Histology Obtained From Prostate Cancer Biopsies|
- Evaluation whether the odds of primary Gleason ≥ 3+4 are greater for image-guided biopsy (based on parametric PET/MRI) than for non-image-guided (standard) biopsy. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Prostate Cancer Imaging
Subjects will receive multi-sequence Magnetic Resonance Imaging (MRI) of the prostate and pelvis. This scan will take approximately 90 minutes.
In addition, a 18F-Choline PET/CT(Positron emission tomography/computed tomography) scan of the abdomen and pelvis is performed. This scan will take about 30 minutes. Subjects may receive an additional 30 minute scan, if needed.
Patients participating in an active surveillance program at the University of Michigan may receive yearly imaging followed by a prostate biopsy procedure.
Procedure: Prostate Cancer Imaging
After imaging is completed, subjects will be scheduled for a prostate biopsy performed as part of their clinical care. If the imaging has identified suspicious lesions in the prostate, these regions will be made visible for the Urologist to be targeted for additional biopsies. These additional biopsies will undergo histological evaluation and further metabolomic testing to better understand metabolic differences between various grades of prostate cancer lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751737
|Contact: Morand R. Piert, M.D.||firstname.lastname@example.org|
|Contact: James Poolemail@example.com|
|United States, Michigan|
|University of Michigan Health Systems||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Morand R. Piert, M.D. 734-936-5388 firstname.lastname@example.org|
|Contact: James Pool 734-615-7391 email@example.com|
|Principal Investigator: Morand R. Piert, M.D.|
|Principal Investigator:||Morand R. Piert, M.D.||University of Michigan Hospital|