Choline PET/CT and MRI for Targeted Prostate Biopsy

University of Michigan63 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Prostate Cancer ImagingPROCEDURE

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.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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