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

NCT ID: NCT04278261

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-09-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Focal therapy

Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer

Group Type EXPERIMENTAL

Focal therapy(high-frequency irreversible electroporation)

Intervention Type PROCEDURE

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

Radical prostatectomy

Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer

Group Type ACTIVE_COMPARATOR

laparoscopic radical prostatectomy

Intervention Type PROCEDURE

Laparoscopic radical prostatectomy

Interventions

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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

Intervention Type PROCEDURE

laparoscopic radical prostatectomy

Laparoscopic radical prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haifeng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital,Tongji University School of Medicine

Locations

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Biming He, MD

Role: CONTACT

+8615502139410

Haifeng Wang, MD

Role: CONTACT

+8613681750891

Other Identifiers

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HIRE-FR-2019001

Identifier Type: -

Identifier Source: org_study_id

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