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

Not Applicable

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12612000523808
• Lead Sponsor: Flack Trustees

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified