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

May 30, 2022 updated by: Shanghai East Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
urinary function measured by ICIQ
Time Frame: 4 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
4 weeks
urinary function measured by ICIQ
Time Frame: 6 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
6 weeks
urinary function measured by ICIQ
Time Frame: 12 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
12 weeks
urinary function measured by ICIQ
Time Frame: 6 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
6 months
urinary function measured by ICIQ
Time Frame: 12 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
12 months
urinary function measured by ICIQ
Time Frame: 24 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
24 months
urinary function measured by EPIC
Time Frame: 4 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
4 weeks
urinary function measured by EPIC
Time Frame: 6 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
6 weeks
urinary function measured by EPIC
Time Frame: 12 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
12 weeks
urinary function measured by EPIC
Time Frame: 6 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
6 months
urinary function measured by EPIC
Time Frame: 12 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
12 months
urinary function measured by EPIC
Time Frame: 24 months
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
Time Frame: 4 weeks
The urinary function will be measured by a separate EPIC pad-use item
4 weeks
urinary function measured by separate EPIC pad-use item
Time Frame: 6 weeks
The urinary function will be measured by a separate EPIC pad-use item
6 weeks
urinary function measured by separate EPIC pad-use item
Time Frame: 12 weeks
The urinary function will be measured by a separate EPIC pad-use item
12 weeks
urinary function measured by separate EPIC pad-use item
Time Frame: 6 months
The urinary function will be measured by a separate EPIC pad-use item
6 months
urinary function measured by separate EPIC pad-use item
Time Frame: 12 months
The urinary function will be measured by a separate EPIC pad-use item
12 months
urinary function measured by separate EPIC pad-use item
Time Frame: 24 months
The urinary function will be measured by a separate EPIC pad-use item
24 months
urinary function measured by IPSS
Time Frame: 4 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
4 weeks
urinary function measured by IPSS
Time Frame: 6 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
6 weeks
urinary function measured by IPSS
Time Frame: 12 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
12 weeks
urinary function measured by IPSS
Time Frame: 6 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
6 months
urinary function measured by IPSS
Time Frame: 12 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
12 months
urinary function measured by IPSS
Time Frame: 24 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
24 months
sexual function measured by EPIC
Time Frame: 4 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
4 weeks
sexual function measured by EPIC
Time Frame: 6 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
6 weeks
sexual function measured by EPIC
Time Frame: 12 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
12 weeks
sexual function measured by EPIC
Time Frame: 6 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
6 months
sexual function measured by EPIC
Time Frame: 12 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
12 months
sexual function measured by EPIC
Time Frame: 24 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
24 months
sexual function measured by IIEF-5
Time Frame: 4 weeks
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
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 24 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with Disease progression
Time Frame: 24 months
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
Time Frame: 4 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
4 weeks
Bowel function
Time Frame: 6 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
6 weeks
Bowel function
Time Frame: 12 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
12 weeks
Bowel function
Time Frame: 6 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
6 months
Bowel function
Time Frame: 12 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
12 months
Bowel function
Time Frame: 24 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
24 months
Quality of life measure by EORTC QLQ-C30
Time Frame: 4 weeks
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
Time Frame: 6 weeks
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
Time Frame: 12 weeks
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 24 months
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
Time Frame: 4 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
4 weeks
Quality of life measure by EPIC urinary domain bother score
Time Frame: 6 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
6 weeks
Quality of life measure by EPIC urinary domain bother score
Time Frame: 12 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
12 weeks
Quality of life measure by EPIC urinary domain bother score
Time Frame: 6 months
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
6 months
Quality of life measure by EPIC urinary domain bother score
Time Frame: 12 months
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
12 months
Quality of life measure by EPIC urinary domain bother score
Time Frame: 24 months
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
24 months
Quality of life measure by EPIC sexual domain bother score
Time Frame: 4 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
4 weeks
Quality of life measure by EPIC sexual domain bother score
Time Frame: 6 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
6 weeks
Quality of life measure by EPIC sexual domain bother score
Time Frame: 12 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
12 weeks
Quality of life measure by EPIC sexual domain bother score
Time Frame: 6 months
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
6 months
Quality of life measure by EPIC sexual domain bother score
Time Frame: 12 months
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
12 months
Quality of life measure by EPIC sexual domain bother score
Time Frame: 24 months
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
24 months
Quality of life measure by EPIC bowel domain bother score
Time Frame: 4 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
4 weeks
Quality of life measure by EPIC bowel domain bother score
Time Frame: 6 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
6 weeks
Quality of life measure by EPIC bowel domain bother score
Time Frame: 12 weeks
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
12 weeks
Quality of life measure by EPIC bowel domain bother score
Time Frame: 6 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
6 months
Quality of life measure by EPIC bowel domain bother score
Time Frame: 12 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
12 months
Quality of life measure by EPIC bowel domain bother score
Time Frame: 24 months
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
24 months
Quality of life measure by HADS
Time Frame: 4 weeks
measured by Hospital Anxiety and Depression Scale (HADS)
4 weeks
Quality of life measure by HADS
Time Frame: 6 weeks
measured by Hospital Anxiety and Depression Scale (HADS)
6 weeks
Quality of life measure by HADS
Time Frame: 12 weeks
measured by Hospital Anxiety and Depression Scale (HADS)
12 weeks
Quality of life measure by HADS
Time Frame: 6 months
measured by Hospital Anxiety and Depression Scale (HADS)
6 months
Quality of life measure by HADS
Time Frame: 12 months
measured by Hospital Anxiety and Depression Scale (HADS)
12 months
Quality of life measure by HADS
Time Frame: 24 months
measured by Hospital Anxiety and Depression Scale (HADS)
24 months
Rates of primary treatment failure
Time Frame: 24 months
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
Time Frame: 4 weeks
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
4 weeks
Rates of adjuvant therapy
Time Frame: 6 weeks
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
6 weeks
Rates of adjuvant therapy
Time Frame: 12 weeks
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
12 weeks
Rates of adjuvant therapy
Time Frame: 6 months
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
6 months
Rates of adjuvant therapy
Time Frame: 12 months
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
12 months
Rates of adjuvant therapy
Time Frame: 24 months
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
24 months
Perioperative data (operative time)
Time Frame: 1 month
operative time
1 month
Perioperative data (hemoglobin loss)
Time Frame: 1 month
hemoglobin loss
1 month
Perioperative data (blood transfusion)
Time Frame: 1 month
the number of patients need blood transfusion
1 month
Perioperative data (the length of hospital stay)
Time Frame: 1 month
the length of hospital stay
1 month
Perioperative data(the length of indwelling catheter stay)
Time Frame: 1 month
the length of indwelling catheter stay
1 month
Pain (measured by a surgical pain scale range from 0 to 10)
Time Frame: 24 hours
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)
Time Frame: 2 weeks
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)
Time Frame: 4 weeks
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)
Time Frame: 6 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 6 months
measured by a surgical pain scale range from 0 to 10
6 months
Adverse effect
Time Frame: 24 months
identified by the Common Terminology Criteria for Adverse Events (CTCAE)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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