Evaluating MRI and biomarkers for prostate cancer detection
EDRN Prostate MRI Biomarker Study and Reference Set
This study is testing if using prostate MRI along with certain blood tests can help doctors better find high-grade prostate cancer in men during their first biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 950 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03784924 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with suspected but undiagnosed prostate cancer who are scheduled for a biopsy as part of routine clinical care.
Not a fit: Patients with a prior diagnosis of prostate cancer or those who have undergone specific prostate surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer detection, leading to better patient outcomes and more tailored treatment approaches.
How similar studies have performed: Other studies have shown promise in using MRI alongside biomarkers for prostate cancer detection, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.