Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

Study Overview
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Brief Summary
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This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

Detailed Description
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Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.

Official Title
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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

Conditions
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Prostate Cancer, Treatment

Intervention / Treatment
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* Procedure: Focal therapy(high-frequency irreversible electroporation)
* Procedure: laparoscopic radical prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age less than 80 years old. PSA<20ng/ml. Clinical stage ≤T2c. Biopsy Gleason score ≤4+4. No evidence of metastasis. Fully understand the clinical trial protocol and sign the informed consent Exclusion Criteria: Any previous treatment to PCa. Any previous surgery within 3 months. Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy). History of any other malignant tumour. Any other conditions that make the investigator judge that participants are not suitable for this trial.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focal therapy<br>Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer | Procedure: Focal therapy(high-frequency irreversible electroporation)<br>* High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer<br>|
| Active Comparator: Radical prostatectomy<br>Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer | Procedure: laparoscopic radical prostatectomy<br>* Laparoscopic radical prostatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 4 weeks | 
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 6 weeks | 
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 12 weeks | 
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 6 months | 
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 12 months | 
| urinary function measured by ICIQ | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score | 24 months | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 4 weeks | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 6 weeks | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 12 weeks | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 6 months | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 12 months | 
| urinary function measured by EPIC | The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score | 24 months | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 4 weeks | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 6 weeks | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 12 weeks | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 6 months | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 12 months | 
| urinary function measured by separate EPIC pad-use item | The urinary function will be measured by a separate EPIC pad-use item | 24 months | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 4 weeks | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 6 weeks | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 12 weeks | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 6 months | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 12 months | 
| urinary function measured by IPSS | The urinary function will be measured by IPSS (International Prostate Symptom Score) | 24 months | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 4 weeks | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 6 weeks | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 12 weeks | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 6 months | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 12 months | 
| sexual function measured by EPIC | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score | 24 months | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 4 weeks | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 6 weeks | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 12 weeks | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 6 months | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 12 months | 
| sexual function measured by IIEF-5 | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Disease progression | is defined either of the following items: (1) clinical evidence of progression (any of the positive results from the bone scan, pelvic MRI/CT, PSMA-PET MR/CT); (2) a positive biopsy (for the H-FIRE arm only); (3) biochemical failure (BCR, for the RP arm only, defined as a serum PSA level higher than 0.4 ng/ml after surgery) | 24 months | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 4 weeks | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 6 weeks | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 12 weeks | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 6 months | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 12 months | 
| Bowel function | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score | 24 months | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 4 weeks | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 6 weeks | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 12 weeks | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 6 months | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 12 months | 
| Quality of life measure by EORTC QLQ-C30 | measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module) | 24 months | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 4 weeks | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 6 weeks | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 12 weeks | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 6 months | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 12 months | 
| Quality of life measure by EPIC urinary domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score | 24 months | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 4 weeks | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 6 weeks | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 12 weeks | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 6 months | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 12 months | 
| Quality of life measure by EPIC sexual domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score | 24 months | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 4 weeks | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 6 weeks | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 12 weeks | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 6 months | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 12 months | 
| Quality of life measure by EPIC bowel domain bother score | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score | 24 months | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 4 weeks | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 6 weeks | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 12 weeks | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 6 months | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 12 months | 
| Quality of life measure by HADS | measured by Hospital Anxiety and Depression Scale (HADS) | 24 months | 
| Rates of primary treatment failure | defined as biopsy show cancer remain at 6 months after H-FIRE procedure, or a PSA level 0.4ng/ml or higher at 3 months after RP procedure | 24 months | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 4 weeks | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 6 weeks | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 12 weeks | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 6 months | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 12 months | 
| Rates of adjuvant therapy | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery | 24 months | 
| Perioperative data (operative time) | operative time | 1 month | 
| Perioperative data (hemoglobin loss) | hemoglobin loss | 1 month | 
| Perioperative data (blood transfusion) | the number of patients need blood transfusion | 1 month | 
| Perioperative data (the length of hospital stay) | the length of hospital stay | 1 month | 
| Perioperative data(the length of indwelling catheter stay) | the length of indwelling catheter stay | 1 month | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 24 hours | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 2 weeks | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 4 weeks | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 6 weeks | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 12 weeks | 
| Pain (measured by a surgical pain scale range from 0 to 10) | measured by a surgical pain scale range from 0 to 10 | 6 months | 
| Adverse effect | identified by the Common Terminology Criteria for Adverse Events (CTCAE) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation