Clinical trial · Interventional
Focal Prostate Radiofrequency Ablation
A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer
NCT02294903CI-TRIAL-00032647ProRAFTunknownN/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)
To assess the early histological outcomes of tissue ablation, adverse events and genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar device to treat localized prostate cancer in men with clinically significant 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 |
|---|---|---|---|
| Coiled Bipolar Radiofrequency Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ProRAFT
- description
- Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation
- interventionNames
- Procedure: Coiled Bipolar Radiofrequency Ablation
Primary outcomes (1)
- measure
- Cancer control outcome
- timeFrame
- 6 months
- description
- To determine the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer using coiled bipolar radiofrequency ablation (Encage)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer * A visible lesion on multiparametric Magnetic Resonance Imaging (mpMRI), that is accessible to a treatment based on radiofrequency bipolar electrodes * Transperineal prostate biopsies (template mapping and/or targeted) correlating with clinically significant lesion in the area of the Magnetic Resonance (MR)-visible lesion * Absence of clinically significant histological disease outside of the planned treatment zone * Radiological stage T1-T3aN0M0 disease, as determined by local guidelines * Serum prostate-specific antigen (serum PSA) \</=15ng/ml within 3 months of screening visit * Life expectancy of more than 10 years * Signed informed consent by patient * An understanding of the English language sufficient to understand written and verbal information about the trial and consent process Exclusion Criteria: * Men who have had previous radiation therapy to the pelvis * Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer * Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * Men with a tumour not visible on mpMRI * Men with an inability to tolerate a transrectal ultrasound (TRUS) * Men allergic to latex * Men who have undergone prior significant rectal surgery preventing insertion of the transrectal ultrasound probe (decided on the type of surgery in individual cases) * Men who have had previous electroporation, radiofrequency ablation, High Intensity Focused Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate * Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within the prior 6 months. These patients may be included within the trial if deferred from consent and screening until at least 6 months following the TURP * Men not fit for major surgery as assessed by a Consultant Anaesthetist * Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images) * Presence of metal implants/stents in the urethra * Men with renal impairment with a Glomerular Filtration Rate (GFR) of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)
References
Publications (0)
Data not yet available
No reference posted for this study.