Evaluating MRI and biomarkers for prostate cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to determine if adding prostate MRI to a validated panel of biomarkers (PSA, PCA3, TMPRSS2:ERG) can improve the specificity for detecting high-grade prostate cancer during initial biopsies. The study will create a prospective cohort to explore the effectiveness of various biomarkers and MRI imaging in identifying patients most likely to benefit from targeted biopsies. Additionally, it will assess longitudinal changes in biomarkers and MRI results to predict the development of high-grade prostate cancer over time.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: John T Wei, MD, MS — University of Michigan
• Study coordinator: Jackie Dahlgren
• Email: jdahlgre@fredhutch.org
• Phone: 206-667-3438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.