Health Trials

Prostate Irreversible Electroporation Study

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-85
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Prostate Irreversible ElectroporationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month oncological outcome

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

Time frame
6-month after treatment

Secondary outcomes

1

6-month and 12-month functional and oncological outcome

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

Time frame
At 6-month and 12-month after treatment
2

30-day complications

30-day complications after study intervention

Time frame
at 30 day after treatment
3

Presence of histologically proven prostate cancer recurrence

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

Time frame
At 12-month after treatment
4

PSA change

PSA change after treatment

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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