Clinical trial · Interventional
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer
NCT04278261CI-TRIAL-00058864unknownN/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 trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.
Conditions
Conditions (2)
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 |
| Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal therapy(high-frequency irreversible electroporation) | Procedure | — | UNRESOLVED |
| laparoscopic radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Focal therapy
- description
- Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer
- interventionNames
- Procedure: Focal therapy(high-frequency irreversible electroporation)
- type
- ACTIVE_COMPARATOR
- label
- Radical prostatectomy
- description
- Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer
- interventionNames
- Procedure: laparoscopic radical prostatectomy
Primary outcomes (36)
- measure
- urinary function measured by ICIQ
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age less than 80 years old. 2. PSA\<20ng/ml. 3. Clinical stage ≤T2c. 4. Biopsy Gleason score ≤4+4. 5. No evidence of metastasis. 6. Fully understand the clinical trial protocol and sign the informed consent Exclusion Criteria: 1. Any previous treatment to PCa. 2. Any previous surgery within 3 months. 3. Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy). 4. History of any other malignant tumour. 5. Any other conditions that make the investigator judge that participants are not suitable for this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.