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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

Tracking Information
First Submitted Date  ICMJE February 19, 2020
First Posted Date  ICMJE February 20, 2020
Last Update Posted Date February 20, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • Urinary incontinence [ Time Frame: 5 years ]
    the rate of urinary incontinence
  • urination function(IPSS scoring) [ Time Frame: 5 years ]
    evaluation of urination function by IPSS scoring
  • sexual function (IIEF-5 scoring) [ Time Frame: 5 years ]
    evaluation of sexual function by IIEF-5 scoring
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Irreversible Electroporation and Radical Prostatectomy in Treating Prostate Cancer
Official Title  ICMJE A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of Irreversible Electroporation and Radical Prostatectomy for Localized Prostate Cancer
Brief Summary This trial is comparing the effects and safety in treating men with prostate cancer between irreversible electroporation and radical prostatectomy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Treatment
Intervention  ICMJE
  • 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
  • Procedure: Radical prostatectomy
    Radical prostatectomy
Study Arms  ICMJE
  • Experimental: Focal therapy
    Using focal therapy(Irreversible electroporation) to treat patients with localized Prostate cancer
    Intervention: Procedure: Focal therapy(Irreversible Electroporation)
  • Active Comparator: Radical prostatectomy
    Using radical prostatectomy to treat patients with localized Prostate cancer
    Intervention: Procedure: Radical prostatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
438
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2027
Estimated Primary Completion Date March 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Biming He, MD +8615502139410 190589109@qq.com
Contact: Haifeng Wang, MD +8613681750891 446720864@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04278261
Other Study ID Numbers  ICMJE HIRE-FR-2019001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai East Hospital
Study Sponsor  ICMJE Shanghai East Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haifeng Wang, MD Shanghai East Hospital,Tongji University School of Medicine
PRS Account Shanghai East Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP