Choline PET/CT and MRI for Targeted Prostate Biopsy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostate Cancer Imaging

• Registration Number: NCT01751737
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-18
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate Cancer Imaging	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan Health Systems; 🇺🇸 Ann Arbor, Michigan, United States