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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
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
Laparoscopic radical prostatectomy
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 4 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 6 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 12 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 6 months
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 12 months
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time frame: 24 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time frame: 4 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time frame: 12 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time frame: 6 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time frame: 12 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time frame: 24 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 4 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 6 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 12 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 6 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 12 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Time frame: 24 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 4 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 6 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 12 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 6 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 12 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time frame: 24 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 4 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 6 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 12 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 6 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 12 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 months
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)
Time frame: 24 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 4 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 6 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 12 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 6 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 12 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 6 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 12 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time frame: 24 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 6 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 12 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time frame: 24 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 6 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 12 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time frame: 24 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 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
Time frame: 24 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 4 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 6 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 12 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 6 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 12 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time frame: 24 months
Perioperative data (operative time)
operative time
Time frame: 1 month
Perioperative data (hemoglobin loss)
hemoglobin loss
Time frame: 1 month
Perioperative data (blood transfusion)
the number of patients need blood transfusion
Time frame: 1 month
Perioperative data (the length of hospital stay)
the length of hospital stay
Time frame: 1 month
Perioperative data(the length of indwelling catheter stay)
the length of indwelling catheter stay
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Adverse effect
identified by the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 24 months