Choline PET/CT and MRI for Targeted Prostate Biopsy

NCT01751737 | Completed DMC

• 1 other identifier: HUM00059514
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; biopsy; 18F-choline; PET; MRI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Prostate Cancer Imaging

EXPERIMENTAL

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

Interventions

Prostate Cancer Imaging PROCEDURE

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.

Prostate Cancer Imaging

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Piert M, Montgomery J, Kunju LP, Siddiqui J, Rogers V, Rajendiran T, Johnson TD, Shao X, Davenport MS. 18F-Choline PET/MRI: The Additional Value of PET for MRI-Guided Transrectal Prostate Biopsies. J Nucl Med. 2016 Jul;57(7):1065-70. doi: 10.2967/jnumed.115.170878. Epub 2016 Mar 16.

  PMID: 26985061 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Morand R. Piert, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 18, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)