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Not yet recruiting NCT04278261

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

No phase Interventional Prostate Cancer Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal therapy(high-frequency irreversible electroporation), laparoscopic radical prostatectomy.
Who it may be relevant to
Registry conditions: Prostate Cancer, Treatment. Basic parameters: up to 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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
  • Procedure laparoscopic radical prostatectomy
    Laparoscopic radical prostatectomy

Primary outcome measures

  • urinary function measured by ICIQ [Time frame: 4 weeks]
  • urinary function measured by ICIQ [Time frame: 6 weeks]
  • urinary function measured by ICIQ [Time frame: 12 weeks]
  • urinary function measured by ICIQ [Time frame: 6 months]
  • urinary function measured by ICIQ [Time frame: 12 months]
  • urinary function measured by ICIQ [Time frame: 24 months]
  • urinary function measured by EPIC [Time frame: 4 weeks]
  • urinary function measured by EPIC [Time frame: 6 weeks]
  • urinary function measured by EPIC [Time frame: 12 weeks]
  • urinary function measured by EPIC [Time frame: 6 months]
Secondary outcome measures (12)
  • Number of patients with Disease progression [Time frame: 24 months]
  • Bowel function [Time frame: 4 weeks]
  • Bowel function [Time frame: 6 weeks]
  • Bowel function [Time frame: 12 weeks]
  • Bowel function [Time frame: 6 months]
  • Bowel function [Time frame: 12 months]
  • Bowel function [Time frame: 24 months]
  • Quality of life measure by EORTC QLQ-C30 [Time frame: 4 weeks]
  • Quality of life measure by EORTC QLQ-C30 [Time frame: 6 weeks]
  • Quality of life measure by EORTC QLQ-C30 [Time frame: 12 weeks]
  • Quality of life measure by EORTC QLQ-C30 [Time frame: 6 months]
  • Quality of life measure by EORTC QLQ-C30 [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age less than 80 years old.
  • PSA<20ng/ml.
  • Clinical stage ≤T2c.
  • Biopsy Gleason score ≤4+4.
  • No evidence of metastasis.
  • Fully understand the clinical trial protocol and sign the informed consent

Exclusion criteria

  • Any previous treatment to PCa.
  • Any previous surgery within 3 months.
  • Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
  • History of any other malignant tumour.
  • Any other conditions that make the investigator judge that participants are not suitable for this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai East Hospital, Tongji University School of Medicine — Shanghai

Identifiers

NCT: NCT04278261 · HIRE-FR-2019001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗