NCT04278261

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
4mo left

Started Jul 2022

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2022Sep 2026

First Submitted

Initial submission to the registry

February 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

February 19, 2020

Last Update Submit

May 30, 2022

Conditions

Prostate CancerTreatment

Keywords

Focal therapyRadical prostatectomyhigh-frequency Irreversible electroporationprostate cancer

Outcome Measures

Primary Outcomes (36)

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    4 weeks

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    6 weeks

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    12 weeks

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    6 months

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    12 months

  • urinary function measured by ICIQ

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

    24 months

  • urinary function measured by EPIC

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

    4 weeks

  • urinary function measured by EPIC

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

    6 weeks

  • urinary function measured by EPIC

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

    12 weeks

  • urinary function measured by EPIC

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

    6 months

  • urinary function measured by EPIC

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

    12 months

  • urinary function measured by EPIC

    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

    The urinary function will be measured by a separate EPIC pad-use item

    4 weeks

  • urinary function measured by separate EPIC pad-use item

    The urinary function will be measured by a separate EPIC pad-use item

    6 weeks

  • urinary function measured by separate EPIC pad-use item

    The urinary function will be measured by a separate EPIC pad-use item

    12 weeks

  • urinary function measured by separate EPIC pad-use item

    The urinary function will be measured by a separate EPIC pad-use item

    6 months

  • urinary function measured by separate EPIC pad-use item

    The urinary function will be measured by a separate EPIC pad-use item

    12 months

  • urinary function measured by separate EPIC pad-use item

    The urinary function will be measured by a separate EPIC pad-use item

    24 months

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    4 weeks

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    6 weeks

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    12 weeks

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    6 months

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    12 months

  • urinary function measured by IPSS

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

    24 months

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    4 weeks

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    6 weeks

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    12 weeks

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    6 months

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    12 months

  • sexual function measured by EPIC

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

    24 months

  • sexual function measured by IIEF-5

    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

    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

    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

    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

    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

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

    24 months

Secondary Outcomes (56)

  • Number of patients with Disease progression

    24 months

  • Bowel function

    4 weeks

  • Bowel function

    6 weeks

  • Bowel function

    12 weeks

  • Bowel function

    6 months

  • +51 more secondary outcomes

Study Arms (2)

Focal therapy

EXPERIMENTAL

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

Procedure: Focal therapy(high-frequency irreversible electroporation)

Radical prostatectomy

ACTIVE COMPARATOR

Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer

Procedure: laparoscopic radical prostatectomy

Interventions

Focal therapy(high-frequency irreversible electroporation)PROCEDURE

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

Focal therapy
laparoscopic radical prostatectomyPROCEDURE

Laparoscopic radical prostatectomy

Radical prostatectomy

Eligibility Criteria

AgeUp to 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Haifeng Wang, MD

    Shanghai East Hospital,Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Biming He, MD

CONTACT

+8615502139410190589109@qq.com

Haifeng Wang, MD

CONTACT

+8613681750891446720864@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 20, 2020

Study Start

July 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)