Clinical trial · Observational
EDRN Prostate MRI Biomarker Study
EDRN Prostate MRI Biomarker Study and Reference Set
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSA | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI prostate | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Initial prostate biopsy
- description
- 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.
- interventionNames
- Diagnostic Test: MRI prostate
Primary outcomes (1)
- measure
- Clinically significant prostate cancer
- timeFrame
- 2 years
- description
- Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available