Clinical trial · Interventional
Pilot Study on Focal Prostate Radio-Frequency Ablation
Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer
NCT01423006CI-TRIAL-00012636completedN/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)
This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized 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 |
|---|---|---|---|
| Radio-Frequency Ablation (RFA) ENCAGE™ | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal Prostate Radio-Frequency Ablation
- description
- Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy.
- interventionNames
- Procedure: Radio-Frequency Ablation (RFA) ENCAGE™
Primary outcomes (1)
- measure
- Negative Prostate Biopsy Rate at Six Months
- timeFrame
- 6 Months
- description
- The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. Evaluable patients for this study will be those who complete up through the six month follow-up/evaluation procedure.
Secondary outcomes (1)
- measure
- Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review * No prior treatment for prostate cancer including hormonal therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Prostate Cancer Clinical Stage T1c * prostate-specific antigen (PSA) \<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy) * Prostate size \<60 cc on transrectal ultrasound * If on anti-coagulation medications, must be able to suspend this therapy for a couple of weeks * Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer Center review) * Minimum of 10 biopsy cores * No biopsy Gleason grade 4 or 5 * Unilateral cancer (only right-sided or left-sided, not bilateral) * No more than 50% cancer in any one biopsy core * No more than 25% of cores containing cancer Exclusion Criteria: * Medically unfit for anesthesia * Histology other than adenocarcinoma * Biopsy does not meet inclusion criteria * Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.