animated
Ongoing Projects > IRE RCT

 

A Multi-Center Randomized Single-Blind Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Prostate Cancer

Current surgical and ablative treatment options for prostate cancer have a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects impair the quality of life of prostate cancer patients and impact on patients’ decision to undergo early, potentially curative interventional treatments. These side effects are due to procedure related damage of the blood vessels, bowel, urethra and/or neurovascular bundle. New treatments that limit damage to these structures have the potential to improve patient outcomes. Ablation with Irreversible Electroporation (IRE) has shown to be effective and safe in destroying tumour cells and to have the potential advantage of sparing surrounding tissue and vital structures such as blood vessels and nerves. This study will examine safety and efficacy of IRE ablation. 

 


Primary study objective:

1. To evaluate differences in side effect profile of patients treated with focal or extended ablation performed with minimally invasive, percutaneous image-guided IRE for the ablation of prostate carcinoma. To determine the treatment related adverse events and genito-urinary side effects measured by CTCAE, the International Index of Erectile Function, International Prostate Symptom Score (IPSS) and use of pads. The groups will be compared.

2. To evaluate differences in quality of life of patients treated with focal or extended ablation performed with minimally invasive, percutaneous image-guided IRE for the ablation of prostate carcinoma. Quality of life-questionnaire (EPIC), Visual Analogue Scale (VAS) pain score, and length of hospital stay will measure this. The groups will be compared.



Secondary study objectives:

3. To evaluate the oncological efficacy of image guided IRE for the focal and extended ablation of prostate carcinoma.

4. To evaluate the efficacy of MRI in the imaging of ablation success and the extend of the ablation zone 6 months and 1, 2, 3, 4, and 5 years post IRE ablation.






 Study design: a two-arm single blind trial.

- Arm 1: Focal ablation of the prostate at the location of positive biopsies.

- Arm 2: Extended ablation of the prostate at the side of the positive biopsies. 

 
Click here to download the protocol

Click here to download the patient information

Click here to download the SAE form

Office   Contact us   Disclaimer   Conditions