Clinical trial · Interventional
Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy
NCT02488096CI-TRIAL-00042895completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine if using MRI can improve cancer detection by identifying potential cancer targets prior to TRUS-guided biopsy in populations that have previous inconclusive results from TRUS-guided biopsies.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI + TRUS-Guided Biopsy | Device | — | UNRESOLVED |
| TRUS-Guided Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TRUS-Guided Biopsy
- description
- Transrectal Ultrasound (TRUS)-guided biopsy systematic 12-core biopsy (standard care)
- interventionNames
- Device: TRUS-Guided Biopsy
- type
- EXPERIMENTAL
- label
- MRI + TRUS-Guided biopsy
- description
- Prostate MRI later followed by systematic 12-score TRUS-guided biopsy + targeted biopsy of additional MRI-detected scores.
- interventionNames
- Device: MRI + TRUS-Guided Biopsy
Primary outcomes (1)
- measure
- Clinically Significant Cancer Detection (Biopsy)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Referred for an ultrasound-guided prostate biopsy * Indication 1: Men without a history of prostate cancer referred to the PAC for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy * Indication 2: Men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the PAC for a follow-up biopsy Exclusion Criteria: * Are unable to consent on their own behalf * Less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding MRI image) * A history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy) * Emergent/urgent biopsy referrals * History of urinary tract infections or prostatitis in the last 3 months * Contraindications to MRI: * Ferromagnetic or otherwise non-MRI compatible aneurysm clips * The presence of an implanted pacemaker or implanted defibrillator device * Contraindication to receiving Gadolinium containing contrast for the which may include past or current kidney disease or injury or kidney transplant * Severe claustrophobia
References
Publications (0)
Data not yet available
No reference posted for this study.