Clinical trial · Interventional
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer
- 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)
This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.
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 |
|---|---|---|---|
| Elevated PSA | — | UNRESOLVED | — |
| Health Status Unknown | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy of Prostate | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Diagnostic Test | — | UNRESOLVED |
| MRI Ultrasound Fusion Guided Biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (SR-Bx)
- description
- Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
- interventionNames
- Procedure: Biopsy of Prostate
- Other: Laboratory Biomarker Analysis
- Diagnostic Test: Magnetic Resonance Imaging
- Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy
- type
- EXPERIMENTAL
- label
- Arm II (MRI, MRUS-Bx, SR-Bx)
- description
- Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy. * If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. * If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
- interventionNames
- Procedure: Biopsy of Prostate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * Note: HIPAA authorization may be included in the informed consent or obtained separately * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 within 3 months (93 days) prior to being registered for protocol * African-American or white men (Hispanic or non-Hispanic) * Prostate biopsy-naive or a single negative biopsy * Having elevated prostate specific antigen (PSA) (\> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE) * Ability to understand the willingness to sign a written informed consent * Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate * Patients must be willing to undergo a biopsy of the prostate Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer * Patients receiving any other investigational agents * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with active inflammatory bowel disease * Patients who are unable to undergo MRI * Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate) * Patients who had \> 1 prior prostate biopsy
References
Publications (0)
Data not yet available