None listed
Conditions
Brief summary
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.
Interventions
Irreversible Electroporation for the ablation of the prostate. Irreversible electroporation is done under general anaesthetic. Two fine needle electrodes are placed percutaneously into the prostate. An electric current is passed between the needle electrodes. This causes the pores of the cell membranes to open killing the cells. the procedure will take about and hour and a half. This is a preliminary study for the researchers to assess the safety of the procedure and to determine the accura
Irreversible Electroporation for the ablation of the prostate. Irreversible electroporation is done under general anaesthetic. Two fine needle electrodes are placed percutaneously into the prostate. An electric current is passed between the needle electrodes. This causes the pores of the cell membranes to open killing the cells. the procedure will take about and hour and a half. This is a preliminary study for the researchers to assess the safety of the procedure and to determine the accuracy of the planned ablation. In this study the IRE procedure is not being done to treat the prostate cancer, it is being done to assess the procedure. A standard radical prostatectomy will be performed 14 to 30 days post-IRE. Post prostatectomy, efficacy of the IRE ablation will be determined by histological examination of the prostate by The Alfred Anatomical Pathology Department and measured as complete or incomplete ablation.
Sponsors
Flack Trustees
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 40 - 75 years 2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2a) 3. Gleason score 7 (3+4 only) or less 4. PSA less than or equal to 10 ng/ml 5. No significant intravesical median lobe on ultrasound 6. Able to visualize prostate gland adequately on transrectal US imaging 7. No prostate calcification greater than 5 mm 8. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure
Exclusion criteria
1. <40, >75 years of age 2. High to medium risk subject with any one of the following: a) PSA greater than 10ng/ml, b) Gleason 7 (4+3 only) or greater, c) Positive bone scan 3. Other Conditions/Status a) Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140/uL b) Active urinary tract infection (“UTI”) c) History of bladder neck contracture d) Anaesthesia Surgical Assignment, category IV or greater e) Interest in future fertility f) History of inflammatory bowel disease g) Concurrent major debilitating illness h) Prior or concurrent malignancy 4. Prior or current therapies a) Biologic therapy for prostate cancer b) Chemotherapy for prostate cancer c) Hormonal therapy for prostate cancer within 3 months of procedure d) Radiotherapy for prostate cancer e) Transurethral prostatectomy (TURP), urethral stent f) Prior major rectal surgery (except haemorrhoids) g) Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure
Outcome results
None listed