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Choline PET/CT and MRI for Targeted Prostate Biopsy

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prostate Cancer Imaging

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate, cancer, biopsy, 18F-choline, PET, MRI

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

University of Michigan Health Systems

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Cancer Imaging

Arm 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.

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01751737

First Posted

November 30, 2012

Last Updated

October 2, 2019

Sponsor

University of Michigan

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT01751737

Brief Title

Choline PET/CT and MRI for Targeted Prostate Biopsy

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

November 2012 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostate Cancer Imaging

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Prostate Cancer Imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morand R. Piert, M.D.

Organizational Affiliation

University of Michigan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26985061

Citation

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.

Results Reference

result

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Choline PET/CT and MRI for Targeted Prostate Biopsy

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