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

Not Applicable

Not yet recruiting

• Conditions: Treatment; Prostate Cancer
• Interventions: Procedure: laparoscopic radical prostatectomy; Procedure: Focal therapy(high-frequency irreversible electroporation)

• Registration Number: NCT04278261
• Lead Sponsor: Shanghai East Hospital

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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-02
• Study Start: 2022-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radical prostatectomy	laparoscopic radical prostatectomy	Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer
Focal therapy	Focal therapy(high-frequency irreversible electroporation)	Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer

Primary Outcome Measures

Name	Time	Method
urinary function measured by EPIC	24 months	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by IPSS	24 months	The urinary function will be measured by IPSS (International Prostate Symptom Score)
sexual function measured by EPIC	24 months	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
urinary function measured by ICIQ	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	24 months	The urinary function will be measured by a separate EPIC pad-use item
sexual function measured by IIEF-5	24 months	The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

Secondary Outcome Measures

Name	Time	Method
Perioperative data (operative time)	1 month	operative time
Quality of life measure by EPIC sexual domain bother score	24 months	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Rates of adjuvant therapy	24 months	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Quality of life measure by EPIC bowel domain bother score	24 months	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EORTC QLQ-C30	24 months	measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Quality of life measure by EPIC urinary domain bother score	24 months	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by HADS	24 months	measured by Hospital Anxiety and Depression Scale (HADS)
Adverse effect	24 months	identified by the Common Terminology Criteria for Adverse Events (CTCAE)
Number of patients with Disease progression	24 months	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)
Perioperative data (hemoglobin loss)	1 month	hemoglobin loss
Perioperative data(the length of indwelling catheter stay)	1 month	the length of indwelling catheter stay
Bowel function	24 months	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Rates of primary treatment failure	24 months	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
Pain (measured by a surgical pain scale range from 0 to 10)	6 months	measured by a surgical pain scale range from 0 to 10
Perioperative data (blood transfusion)	1 month	the number of patients need blood transfusion
Perioperative data (the length of hospital stay)	1 month	the length of hospital stay

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China