Clinical trial · Interventional
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)
- 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 is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.
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 |
|---|---|---|---|
| Bipolar Radiofrequency Focal Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bipolar Radiofrequency Focal Ablation
- description
- Men identified as having suspicious regions on an Prostatic multi-parametric MRI (mpMRI) of the prostate will be considered for enrollment. If followed by a positive MRI-US targeted biopsy of the prostate, men who be offered enrollment into the study. All men enrolled in the study will undergo bipolar radiofrequency ablation. Efficacy will be assessed through MRI-US biopsy after focal bipolar RFA.
- interventionNames
- Procedure: Bipolar Radiofrequency Focal Ablation
Primary outcomes (1)
- measure
- Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
- timeFrame
- 6 months after focal bipolar radiofrequency ablation (RFA)
- description
- The primary endpoint of the trial will be assessed at 6 months after focal bipolar RFA by repeat mp-MRI imaging and fusion biopsy. Treatment efficacy, defined as a negative, will be determined by the results of the MRI-US targeted biopsy that will include regions treated by focal bipolar RFA.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Subject Population: * Men 40-80 years of age * Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy * No prior treatment for prostate cancer * Prostate Cancer Clinical Stage T1c * Prostate-specific antigen (PSA)\<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy) * Declined all standard treatment options Pre-enrollment biopsy parameters: * Minimum of 12 biopsy cores * Gleason 6 (3+3) or 7 (3+4) Final enrollment biopsy parameters after fusion biopsy: * 12 standard biopsy cores plus targeted regions based upon MRI * Gleason 6 (3+3) or 7 (3+4) * No demonstrated cancer diameter \>1.2 cm Exclusion Criteria: * Histology other than adenocarcinoma * Biopsy does not meet inclusion criteria * History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA) * History of prior pelvic radiation * Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months * Contraindication for Multiparametric-MRI
References
Publications (0)
Data not yet available