Prostate Cancer
Conditions
Keywords
Focal therapy
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.
Interventions
DEVICEProstate 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month oncological outcome | 6-month after treatment | 6-month oncological outcome after Prostate Irreversible Electroporation treatment, as defined by multiparametric MRI result of prostate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-month and 12-month functional and oncological outcome | 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 |
| 30-day complications | at 30 day after treatment | 30-day complications after study intervention |
| Presence of histologically proven prostate cancer recurrence | At 12-month after treatment | Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases |
| PSA change | At 3-month, 6-month, 9-month and 12-month after treatment | PSA change after treatment |
Countries
Hong Kong
Contacts
CONTACTChi Hang Yee, MBBS
PRINCIPAL_INVESTIGATORChi Hang Yee, MBBS
Chinese University of Hong Kong
Outcome results
None listed