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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04278261
• Other study ID #: HIRE-FR-2019001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2022
• Source: Shanghai East Hospital
• Contact: Biming He, MD
• Phone: +8615502139410
• Email: 190589109[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: September 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Treatment

Intervention

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
• laparoscopic radical prostatectomy
Laparoscopic radical prostatectomy

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	4 weeks
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	6 weeks
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	12 weeks
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	6 months
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	12 months
Primary	urinary function measured by ICIQ	The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score	24 months
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	4 weeks
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	6 weeks
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	12 weeks
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	6 months
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	12 months
Primary	urinary function measured by EPIC	The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score	24 months
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	4 weeks
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	6 weeks
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	12 weeks
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	6 months
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	12 months
Primary	urinary function measured by separate EPIC pad-use item	The urinary function will be measured by a separate EPIC pad-use item	24 months
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	4 weeks
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	6 weeks
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	12 weeks
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	6 months
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	12 months
Primary	urinary function measured by IPSS	The urinary function will be measured by IPSS (International Prostate Symptom Score)	24 months
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	4 weeks
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	6 weeks
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	12 weeks
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	6 months
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	12 months
Primary	sexual function measured by EPIC	The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score	24 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	4 weeks
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	6 weeks
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	12 weeks
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	6 months
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	12 months
Secondary	Bowel function	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	4 weeks
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	6 weeks
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	12 weeks
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	6 months
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	12 months
Secondary	Quality of life measure by EPIC urinary domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score	24 months
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	4 weeks
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	6 weeks
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	12 weeks
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	6 months
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	12 months
Secondary	Quality of life measure by EPIC sexual domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score	24 months
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	4 weeks
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	6 weeks
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	12 weeks
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	6 months
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	12 months
Secondary	Quality of life measure by EPIC bowel domain bother score	measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score	24 months
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	4 weeks
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	6 weeks
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	12 weeks
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	6 months
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	12 months
Secondary	Quality of life measure by HADS	measured by Hospital Anxiety and Depression Scale (HADS)	24 months
Secondary	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
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	4 weeks
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	6 weeks
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	12 weeks
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	6 months
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	12 months
Secondary	Rates of adjuvant therapy	defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery	24 months
Secondary	Perioperative data (operative time)	operative time	1 month
Secondary	Perioperative data (hemoglobin loss)	hemoglobin loss	1 month
Secondary	Perioperative data (blood transfusion)	the number of patients need blood transfusion	1 month
Secondary	Perioperative data (the length of hospital stay)	the length of hospital stay	1 month
Secondary	Perioperative data(the length of indwelling catheter stay)	the length of indwelling catheter stay	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse effect	identified by the Common Terminology Criteria for Adverse Events (CTCAE)	24 months