Clinical trial · Interventional
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
NCT03823001CI-TRIAL-00058637withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| virtual biopsy (VB) monitoring protocol | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Virtual prostate biopsy (VB) monitoring
- description
- Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented: 1. PSA bi-annually or more often according to the discretion of the urologist. 2. Annual DRE. 3. Visit with the urologist bi-annually. 4. Multi-parametric MRI (mpMRI) every year for 3 years. 5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
- interventionNames
- Diagnostic Test: virtual biopsy (VB) monitoring protocol
Primary outcomes (1)
- measure
- Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
- timeFrame
- Up to 3 years from start of study
- description
- Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or * Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or * Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2). Exclusion Criteria: * Positive DRE; * PSA \> 10 ng/ml or unstable PSA (doubling time \<3 years) during the last year prior to enrolling in this study; * PSAD \> 0.15 (calculated using most recent PSA divided by MRI prostate volume); * First degree relative diagnosed with prostate cancer * First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer. * Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.
References
Publications (0)
Data not yet available
No reference posted for this study.