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

Tongji University

Status: Not yet enrolling

Conditions: Treatment; Prostate Cancer

Treatments: Procedure: laparoscopic radical prostatectomy; Procedure: Focal therapy(high-frequency irreversible electroporation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04278261

HIRE-FR-2019001

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 estimated patients

Sex: Male

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups

Focal therapy

Experimental group

Description:

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

Treatment:

Procedure: Focal therapy(high-frequency irreversible electroporation)

Radical prostatectomy

Active Comparator group

Description:

Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer

Treatment:

Procedure: laparoscopic radical prostatectomy