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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal therapy | Experimental | Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer |
|
| Radical prostatectomy | Active Comparator | Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal therapy(high-frequency irreversible electroporation) | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biming He, MD | Contact | +8615502139410 | 190589109@qq.com | |
| Haifeng Wang, MD | Contact | +8613681750891 | 446720864@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang, MD | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| laparoscopic radical prostatectomy | Procedure | Laparoscopic radical prostatectomy |
|
| 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 |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |