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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Treatment
• Intervention / Treatment: Procedure: Focal therapy(high-frequency irreversible electroporation); Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Focal therapy; Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer	Procedure: Focal therapy(high-frequency irreversible electroporation); 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
ACTIVE_COMPARATOR: Radical prostatectomy; Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer	Procedure: laparoscopic radical prostatectomy; Laparoscopic radical prostatectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2026
• Study Completion (ANTICIPATED): September 1, 2026

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (ACTUAL): February 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: prostate cancer; Radical prostatectomy; Focal therapy; high-frequency Irreversible electroporation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HIRE-FR-2019001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No