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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Irreversible Electroporation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month oncological outcome | 6-month oncological outcome after Prostate Irreversible Electroporation treatment, as defined by multiparametric MRI result of prostate | 6-month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 6-month and 12-month after treatment |
| 30-day complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Hang Yee, MBBS | Contact | +852 35053933 | yeechihang@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Chi Hang Yee, MBBS | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, the Chinese University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
30-day complications after study intervention |
| at 30 day after treatment |
| Presence of histologically proven prostate cancer recurrence | Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases | At 12-month after treatment |
| PSA change | PSA change after treatment | At 3-month, 6-month, 9-month and 12-month after treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |