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NCT Number: NCT06886321

Prostate Irreversible Electroporation Study

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, the Chinese University of Hong Kong

Hong Kong

Location contact

Chi Hang Yee, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate Irreversible Electroporation

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.

Primary outcomes

  1. 6-month oncological outcome

    Time frame: 6-month after treatment

    6-month oncological outcome after Prostate Irreversible Electroporation treatment, as defined by multiparametric MRI result of prostate

Secondary outcomes

  1. 6-month and 12-month functional and oncological outcome

    Time frame: At 6-month and 12-month after treatment

    6-month and 12-month functional and oncological outcome after Prostate Irreversible Electroporation treatment by questionnaires and multiparametric MRI result of prostate

  2. 30-day complications

    Time frame: at 30 day after treatment

    30-day complications after study intervention

  3. Presence of histologically proven prostate cancer recurrence

    Time frame: At 12-month after treatment

    Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases

  4. PSA change

    Time frame: At 3-month, 6-month, 9-month and 12-month after treatment

    PSA change after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Hang Yee, MBBS

CONTACT

[email protected]

+852 35053933

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Evaluation of the Effectiveness of Irreversible Electroporation for the Treatment of Prostate Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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