Clinical trial · Interventional
Focal Prostate Radio-Frequency Ablation
Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
NCT02328807CI-TRIAL-00053131completedN/AResults postedClinicalTrials.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 main purpose of this study is to evaluate the safety and efficacy of focal (targeted) Radio-Frequency Ablation (RFA) in men with low or intermediate-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) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radio-Frequency Ablation (RFA)
- description
- Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
- interventionNames
- Procedure: Radio-Frequency Ablation (RFA)
Primary outcomes (1)
- measure
- Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
- timeFrame
- 6 months
- description
- The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method.
Secondary outcomes (2)
- measure
- Number of Participants With Treatment Related Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men 18 years of age or older * Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review * No prior treatment for prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1 * Prostate Cancer Clinical Stage T2a and below * PSA \<10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy) * Prostate size \<60 cc on transrectal ultrasound * Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral). Exclusion Criteria: * Men less than 18 years of age * 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.