Choline PET/CT and MRI for Targeted Prostate Biopsy

University of Michigan

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Prostate Cancer Imaging

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01751737

HUM00059514

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Prostate Cancer Imaging

Experimental group

Description:

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.

Treatment:

Procedure: Prostate Cancer Imaging