Biopsy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Prostate Cancer+1 More
Biopsy - Procedure
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This study tests whether it is feasible to use the OmnEcoil system for transrectal MRI to visualize and biopsy suspicious lesions in the prostate. The OmnEcoil device combines an endorectal coil (a type of wire placed within the rectum during diagnostic endorectal MRI to take better images of the prostate) with a multichannel needle guide for biopsy. The OmnEcoil system is designed to allow for MRI to be used at the same time to image the prostate and aid in the biopsy of the suspected prostate cancer. Usually, these are performed as two separate MRI procedures at two separate times.

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Start of procedure to 30 days after end of procedure

Day 30
Early Feasibility: Incidence of biopsy-related grade ≥3 adverse events (Safety of the OmnEcoil system)
Traditional Feasibility: Incidence of biopsy-related grade ≥3 adverse events (Safety of the OmnEcoil system)
Day 1
Early Feasibility: Acquisition Rate of OmnEcoil tissue samples
Early Feasibility: Physician experience using OmnEcoil system
Traditional Feasibility: Acquisition Rate of OmnEcoil tissue samples
Traditional Feasibility: Proportion of cancer containing biopsies of dominant targets.

Trial Safety

Trial Design

1 Treatment Group

Diagnostic (endorectal MRI, MRI-targeted biopsy)
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Biopsy · No Placebo Group · N/A

Diagnostic (endorectal MRI, MRI-targeted biopsy)Experimental Group · 3 Interventions: Biopsy, Endorectal Magnetic Resonance Imaging, OmnEcoil · Intervention Types: Procedure, Procedure, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: start of procedure to 30 days after end of procedure

Trial Background

Fergus Coakley, Principal Investigator
Principal Investigator
OHSU Knight Cancer Institute
Closest Location: OHSU Knight Cancer Institute · Portland, OR
Photo of Portland  1Photo of Portland  2Photo of Portland  3
2003First Recorded Clinical Trial
19 TrialsResearching Prostate Cancer
102 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 45 years.
You have persistent elevated PSA level and/or abnormal digital rectal exam.
OHSU has access to the patient's medical record and MRI images.
You have a high-value biopsy target on multiparametric MRI as evaluated by study radiologists.
Patient able to lie prone in MRI for OmnEcoil biopsy procedure.
You have a platelet count of at least 50,000.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.