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Prostate Irreversible Electroporation Study

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Not yet enrolling

Conditions

Prostate Cancer

Treatments

Device: Prostate Irreversible Electroporation

Study type

Interventional

Funder types

Other

Identifiers

NCT06886321
CRE-2023.215

Details and patient eligibility

About

Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, Irreversible electroporation has evolved over the past decades and can be a reliable treatment option. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management.

Enrollment

10 estimated patients

Sex

Male

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men aged between 40 - 85 years
  • Visible index lesion(s) on MRI
  • Found to have localized prostate cancer after MRI-USG fusion targeted biopsy or USG-guided template biopsy: Clinical tumour stage <=T2, or Gleason score <=7, or PSA <= 20 ng/ml

Exclusion criteria

  • Patients unfit for contrast MRI exam
  • Patients with active urinary tract infection
  • Patients with bladder pathology including bladder stone and bladder cancer
  • Patients with urethral stricture
  • Patients with neurogenic bladder and/or sphincter abnormalities
  • Patients who fail to give informed consent

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Prostate Irreversible Electroporation
Experimental group
Treatment:
Device: Prostate Irreversible Electroporation

Trial contacts and locations

1

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Central trial contact

Chi Hang Yee, MBBS

Data sourced from clinicaltrials.gov

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