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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Shanghai East Hospital
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- urinary function measured by EPIC
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age less than 80 years old.
- •PSA\<20ng/ml.
- •Clinical stage ≤T2c.
- •Biopsy Gleason score ≤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.
Outcomes
Primary Outcomes
urinary function measured by EPIC
Time Frame: 24 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by IPSS
Time Frame: 24 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
sexual function measured by EPIC
Time Frame: 24 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
urinary function measured by ICIQ
Time Frame: 24 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by separate EPIC pad-use item
Time Frame: 24 months
The urinary function will be measured by a separate EPIC pad-use item
sexual function measured by IIEF-5
Time Frame: 24 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Secondary Outcomes
- Perioperative data (operative time)(1 month)
- Perioperative data (hemoglobin loss)(1 month)
- Rates of adjuvant therapy(24 months)
- Quality of life measure by EPIC sexual domain bother score(24 months)
- Quality of life measure by EPIC bowel domain bother score(24 months)
- Quality of life measure by EORTC QLQ-C30(24 months)
- Quality of life measure by EPIC urinary domain bother score(24 months)
- Quality of life measure by HADS(24 months)
- Adverse effect(24 months)
- Number of patients with Disease progression(24 months)
- Perioperative data(the length of indwelling catheter stay)(1 month)
- Bowel function(24 months)
- Rates of primary treatment failure(24 months)
- Pain (measured by a surgical pain scale range from 0 to 10)(6 months)
- Perioperative data (blood transfusion)(1 month)
- Perioperative data (the length of hospital stay)(1 month)