Choline PET/CT and MRI for Targeted Prostate Biopsy

Study Overview
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Brief Summary
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This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Prostate Cancer Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males 40 years of age or older scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A) Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B) Exclusion Criteria: Androgen ablation (hormone treatment) within the last 3 months Prostate biopsy within 6 weeks prior to PET or MRI imaging Active inflammatory bowel disease within the last 6 months Acute prostatitis within the last 6 months A non-urologic bacterial infection requiring active treatment with antibiotics Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years Previous radiation treatment of the pelvis Symptomatic distal rectal stenosis Known hypersensitivity to glucagon Pheochromocytoma, insulinoma or galactosemia Insulin-dependent diabetes

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Cancer Imaging<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-choline, MRI, prostate, cancer, biopsy, PET