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Comparison of Irreversible Electroporation and Radical Prostatectomy in Treating Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04278261
Recruitment Status : Not yet recruiting
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

Brief Summary:
This trial is comparing the effects and safety in treating men with prostate cancer between irreversible electroporation and radical prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Treatment Procedure: Focal therapy(Irreversible Electroporation) Procedure: Radical prostatectomy Not Applicable

Detailed Description:
Four hundred and thirty-eight 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, irreversible electroporation; group 2, radical prostatectomy. The primary outcome is the 5-year free tumor progression rate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of Irreversible Electroporation and Radical Prostatectomy for Localized Prostate Cancer
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2027
Estimated Study Completion Date : September 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Focal therapy
Using focal therapy(Irreversible electroporation) to treat patients with localized Prostate cancer
Procedure: Focal therapy(Irreversible Electroporation)
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 radical prostatectomy to treat patients with localized Prostate cancer
Procedure: Radical prostatectomy
Radical prostatectomy




Primary Outcome Measures :
  1. The 5-year free tumor progression rate [ Time Frame: 5 years ]
    The percentage of all treated patients whose tumors did not recur within 5 years 1.For Irreversible electroporation: detect tumor after treatment by each of the followings: prostate biopsy, mpMRI, ECT, PSMA-ECT or PSMA-PET 2.For radical prostatectomy: detect tumor after treatment by each of the followings: mpMRI, ECT, PSMA-ECT or PSMA-PET of treatment


Secondary Outcome Measures :
  1. Urinary incontinence [ Time Frame: 5 years ]
    the rate of urinary incontinence

  2. urination function(IPSS scoring) [ Time Frame: 5 years ]
    evaluation of urination function by IPSS scoring

  3. sexual function (IIEF-5 scoring) [ Time Frame: 5 years ]
    evaluation of sexual function by IIEF-5 scoring



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The therapy must be thoroughtly understood with the agreement signed
  2. Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
  3. Patients must have confirmed prostate cancer by template-guide prostate maping biopsy
  4. PSA<20ng/ml,T1a-T2c,Gleason Score<8
  5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
  6. No prostatic calculus or prostatic calculus≤5mm
  7. Age ≥ 40 - ≤ 90years
  8. Life expectancy of greater than 5 years(WHO Performance Status 0-1)
  9. Patients with fertility are willing to take contraceptive measures until the end of the trial

Exclusion Criteria:

  1. Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
  2. Patients underwent other surgery before less than 3 months.
  3. Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
  4. Patients with clinically significant cardiovascular disease or other serious diseases
  5. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs.
  6. Patients with history of epilepsy
  7. Patients with other malignant tumor or patients with hiv.
  8. Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
  9. Patients with participation in another clinical trial less than 3 months.
  10. Patients with the judge that they are not suitable for this clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278261


Contacts
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Contact: Biming He, MD +8615502139410 190589109@qq.com
Contact: Haifeng Wang, MD +8613681750891 446720864@qq.com

Locations
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China, Shanghai
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai, China, 200120
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Haifeng Wang, MD Shanghai East Hospital,Tongji University School of Medicine
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04278261    
Other Study ID Numbers: HIRE-FR-2019001
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai East Hospital:
Focal therapy
Radical prostatectomy
Irreversible electroporation
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases