Biopsy of Prostate for Unknown Health Status

Chesapeake Urology Associates, Towson, MD
Unknown Health Status+1 More ConditionsBiopsy of Prostate - Procedure
Eligibility

Study Summary

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

Eligible Conditions
  • Unknown Health Status
  • Elevated Prostate Specific Antigen (PSA)

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 5 years

Up to 5 years
Biopsy detection rate of clinically significant prostate cancer
Highest Gleason score
Presence of any of the complications

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm I (SR-Bx)
1 of 2
Arm II (MRI, MRUS-Bx, SR-Bx)
1 of 2

Active Control

Experimental Treatment

400 Total Participants · 2 Treatment Groups

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

Arm II (MRI, MRUS-Bx, SR-Bx)Experimental Group · 4 Interventions: MRI Ultrasound Fusion Guided Biopsy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Biopsy of Prostate · Intervention Types: DiagnosticTest, Other, DiagnosticTest, Procedure
Arm I (SR-Bx)ActiveComparator Group · 4 Interventions: MRI Ultrasound Fusion Guided Biopsy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Biopsy of Prostate · Intervention Types: DiagnosticTest, Other, DiagnosticTest, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
850 Previous Clinical Trials
1,433,606 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,234,998 Total Patients Enrolled
Inderbir GillPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
5 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Men who identify as African-American or white (regardless of Hispanic ethnicity).
You are willing to have a procedure called a biopsy of the prostate.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.