Prostate Irreversible Electroporation Study

NCT ID: NCT06886321

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate Irreversible Electroporation

Group Type: EXPERIMENTAL

Prostate Irreversible Electroporation

Intervention Type: DEVICE

The Prostate Irreversible Electroporation procedure was performed in our institution by a single urologist using an Prostate Irreversible Electroporation device and 18-gauge electrodes (Nanoknife®; Angiodynamics, Queensbury, NY, USA). All patients were positioned in lithotomy position under general anesthesia. A transrectal ultrasound was used to visualize the prostate and a brachytherapy grid was used to place the electrodes. An indwelling catheter was placed to empty the bladder. Four to six electrodes were placed through the perineum via the template grid to surround the targeted lesion. The lesion was defined based on prostate biopsy and MRI images. The active tip varied between 15- and 20-mm exposure. The distances between the electrodes were measured using TRUS and entered into the Nanoknife system. An initial ten pulses were delivered to ensure sufficient current was delivered between the electrodes (20-40 A). If sufficient then the remaining 80 pulses were given.

Interventions

Prostate Irreversible Electroporation

The Prostate Irreversible Electroporation procedure was performed in our institution by a single urologist using an Prostate Irreversible Electroporation device and 18-gauge electrodes (Nanoknife®; Angiodynamics, Queensbury, NY, USA). All patients were positioned in lithotomy position under general anesthesia. A transrectal ultrasound was used to visualize the prostate and a brachytherapy grid was used to place the electrodes. An indwelling catheter was placed to empty the bladder. Four to six electrodes were placed through the perineum via the template grid to surround the targeted lesion. The lesion was defined based on prostate biopsy and MRI images. The active tip varied between 15- and 20-mm exposure. The distances between the electrodes were measured using TRUS and entered into the Nanoknife system. An initial ten pulses were delivered to ensure sufficient current was delivered between the electrodes (20-40 A). If sufficient then the remaining 80 pulses were given.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chi Hang Yee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Hang Yee, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital, the Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Chi Hang Yee, MBBS

Role: CONTACT

yeechihang@surgery.cuhk.edu.hk

+852 35053933

Other Identifiers

CRE-2023.215

Identifier Type: -

Identifier Source: org_study_id