Choline PET/CT and MRI for Targeted Prostate Biopsy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751737
• Other study ID #: HUM00059514
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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