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The safety and efficacy of Irreversible Electroporation for the ablation of prostate cancer assessed by procedural related side effects and post prostatectomy histology: A pilot study
Other Non-Commercial Sponsor
Ablation techniques are used to directly destroy tumours within an organ. The location of the tumours is predetermined with imaging. With image guidance, needles are inserted through the skin (percutaneously) into the tumour and an energy field (heat, cold, microwaves, ultrasound etc) is used to destroy the tumour cells. Irreversible Electroporation (IRE) is a new ablation technology that has been shown to have advantages over other more established technologies. It uses high voltage direct electrical current to open the cell membranes and destroy tumours but spares surrounding tissues and vital structures such as nerves and blood vessels. The Study: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, mainly incontinence and erectile dysfunction, that diminish the quality of life of prostate cancer sufferers and impact on patients decision to undergo early, potentially curative treatments. These side effects are due to procedure related damage of the blood vessels, ureter 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 been shown to be effective in destroying tumour cells and to have the advantage of sparing surrounding tissue and vital structures such as blood vessels and neurones. It is therefore postulated that this advantage may help reduce or avoid these side effects. The purpose of this study is to evaluate the safety, precision and cost of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer. Who is it for? This study is eligible for up to six patients diagnosed with confirmed prostate cancer with no evidence of lymph node or distant metastases, categorised as low risk (as defined by the American Urological Association Guideline for Management of Clinically Localized Prostate Cancer: 2007 Update, as a clinical score of T1-2a, a Gleason score of 7 (3+4 only) or less, and a PSA less than or equal to 10 ng/ml) and scheduled for a radical prostatectomy by the treating urologist will have the IRE procedure 14-30 days before the prostatectomy. Participants will have preprocedure urological and prostate cancer assessments (Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS). A specified ablation zone will be predetermined using the same preplanning used for conventional brachytherapy treatment. The procedure for planning and performing brachytherapy is well established in the Radiation Oncology Department at The Alfred. It involves determining the volume (size and shape) of the prostate. Trial Details In this study, you will undergo Irreversible Electroporation (IRE) procedure which involves two fine needle electrodes being placed percutaneously into the prostate in the same way as a biopsy is performed. An electric current is passed between the needle electrodes, which causes the pores of the cell membranes to open, thereby killing the cells. The procedure will take about an hour and a half, and will be performed by either the study urologist or study radiation oncologist with assistance with the technology by the study radiologists. You will then be followed up at 1, 2 and 4 weeks, where testing for any adverse events and urological and prostate assessments will be performed. When the prostate is removed it will be examined histologically (microscopically) to ascertain the effectiveness of ablation by the Anatomical Pathology Department at The Alfred. We will be able to know if complete ablation of the specified area was achieved.