Recruiting

Prostate MRI

Sponsor:

University of Michigan

Code:

NCT03784924

Conditions

PSA

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI prostate

Study Details

Brief summary:

The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.

Conditions

PSA

Prostate Cancer

Study ID

NCT03784924

Start date

Feb 4, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men with suspected but undiagnosed prostate cancer
  • To be scheduled/scheduled for biopsy as routine clinical care

Exclusion Criteria:

  • Inability to obtain blood and urine per SOP or conduct an attentive DRE
  • Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
  • Prior diagnosis of prostate cancer
  • Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
  • Participating in clinical trial for prostate disease
  • Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
  • Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose

Study Design

Enrollment

950 participants

Anticipated

Interventions and Outcome Measures

Arms

Initial prostate biopsy

Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.

Interventions

MRI prostate

MRI and laboratory biomarkers

Primary outcome measure

  • Clinically significant prostate cancer [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jackie Dahlgren

206-667-3438jdahlgre@fredhutch.org

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Simpa S Salami, MD

7346156662simpa@med.umich.edu

Rabia Martin

7347637508rabia@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Prostate cancer
  • psa
  • early detection
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-17.