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Diagnostic Methods for Prostate Cancer

N/A
Recruiting
Led By Inderbir Gill
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
Patients must be willing to undergo a biopsy of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial looks at two ways of diagnosing prostate cancer to see which is more accurate.

Who is the study for?
This trial is for African American and white men with elevated PSA levels (>2.5 ng/ml) who have either never had a prostate biopsy or had one negative biopsy, no palpable nodule on exam, and are in good health (ECOG status <=1). They must consent to the study's procedures and not have active bowel disease, recent chemo or radiotherapy for other conditions, unstable heart disease, severe psychiatric issues, inability to undergo MRI, or multiple prior biopsies.Check my eligibility
What is being tested?
The trial is testing two methods of diagnosing prostate cancer in men with high PSA: systematic random biopsy versus MRI-ultrasound fusion guided biopsy. It aims to determine which method is more accurate for detection. Participants will be randomly assigned to one of these diagnostic approaches.See study design
What are the potential side effects?
Potential side effects from the biopsies may include discomfort at the biopsy site, bleeding, infection risk post-procedure and temporary difficulty urinating. The MRI might cause discomfort due to lying still for a period of time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My PSA level is above 2.5 ng/ml and I have no lumps on prostate exam.
Select...
I am willing to have a prostate biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy detection rate of clinically significant prostate cancer
Secondary outcome measures
Presence of any of the complications
Other outcome measures
Highest Gleason score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (MRI, MRUS-Bx, SR-Bx)Experimental Treatment4 Interventions
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy. If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
Group II: Arm I (SR-Bx)Active Control4 Interventions
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,595,888 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,605 Total Patients Enrolled
Inderbir GillPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Biopsy of Prostate Clinical Trial Eligibility Overview. Trial Name: NCT03234556 — N/A
Unknown Health Status Research Study Groups: Arm I (SR-Bx), Arm II (MRI, MRUS-Bx, SR-Bx)
Unknown Health Status Clinical Trial 2023: Biopsy of Prostate Highlights & Side Effects. Trial Name: NCT03234556 — N/A
Biopsy of Prostate 2023 Treatment Timeline for Medical Study. Trial Name: NCT03234556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are implementing this trial currently?

"Multiple medical centres have begun recruiting for this clinical trial, including the University of Maryland in Baltimore, UT Southwestern/Simmons Cancer Center-Dallas in Dallas and USC / Norris Comprehensive Cancer Centre in Los Angeles. Additionally, four other research sites are also enrolling participants."

Answered by AI

Is recruitment for this investigation actively taking place?

"According to clinicaltrials.gov, this medical investigation is actively seeking volunteers. The trial was initially posted on September 25th 2017 and most recently updated on August 5th 2022."

Answered by AI

What is the current size of enrolment for this trial?

"Affirmative. The clinical trial is still looking for individuals to take part in the study and its details were last updated on August 5th 2022, as seen on clinicaltrials.gov. 400 persons must be recruited from 7 different medical sites before the research can begin."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
2017. "Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03234556.
All > Prostate Cancer Anaheim
~67 spots leftby Sep 2025
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