Choline PET/CT and MRI for Targeted Prostate Biopsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Morand Piert, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01751737
First received: November 30, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Prostate Cancer Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Procedure: Prostate Cancer Imaging
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751737

Contacts
Contact: Morand R. Piert, M.D. 734-936-5388 mpiert@umich.edu
Contact: James Pool 734-615-7391 jampool@med.umich.edu

Locations
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Morand R. Piert, M.D.    734-936-5388    mpiert@umich.edu   
Contact: James Pool    734-615-7391    jampool@med.umich.edu   
Principal Investigator: Morand R. Piert, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Morand R. Piert, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Morand Piert, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01751737     History of Changes
Other Study ID Numbers: HUM00059514
Study First Received: November 30, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
prostate
cancer
biopsy
18F-choline
PET
MRI

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014