Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study.
Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation)
Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour.
Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal ablation | Active Comparator | Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE |
|
| Extended ablation | Active Comparator | Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible Electroporation (Nanoknife) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer | To determine post procedural side-effects and Quality of life measured by International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oncological efficacy IRE ablation of prostate cancer. | To determine if IRE focal ablation procedure is as effective as extended ablation measured by PSA, standardised transrectal biopsies and MRI findings in follow-up. To determine accurateness of ablation zone detection by MRI. | 5 years |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean de la Rosette, MD, PhD | Clinical Research Office of the Endourological Society | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36723911 | Derived | Zhang K, Teoh J, Laguna P, Dominguez-Escrig J, Barret E, Ramon-Borja JC, Muir G, Bohr J, de Reijke TM, Pelechano Gomez P, Ng CF, Sanchez-Salas R, de la Rosette J. Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial. JAMA Surg. 2023 Apr 1;158(4):343-349. doi: 10.1001/jamasurg.2022.7516. | |
| 27150293 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Derived |
| Scheltema MJ, van den Bos W, de Bruin DM, Wijkstra H, Laguna MP, de Reijke TM, de la Rosette JJ. Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial. BMC Cancer. 2016 May 5;16:299. doi: 10.1186/s12885-016-2332-z. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |