Τίτλος:
The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: A multicentre prospective human in vivo pilot study protocol
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Ethics and dissemination: The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. Conclusions: This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue.
Introduction: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer.
Methods and analysis: In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone.
Συγγραφείς:
Van Den Bos, W.
De Bruin, D.M.
Muller, B.G.
Varkarakis, I.M.
Karagiannis, A.A.
Zondervan, P.J.
Laguna Pes, M.P.
Veelo, D.P.
Savci Heijink, C.D.
Engelbrecht, M.R.W.
Wijkstra, H.
De Reijke, T.M.
De La Rosette, J.J.M.C.H.
Περιοδικό:
BMJ Open Gastroenterology
Εκδότης:
BMJ Publishing Group
Λέξεις-κλειδιά:
prostate specific antigen, analgesia; Article; cancer patient; clinical article; contrast enhancement; diffusion weighted imaging; echography; electroporation; follow up; functional status; histopathology; human; in vivo study; International Index of Erectile Function; International Prostate Symptom Score; irreversible electroporation; irreversible electroporation device; length of stay; male; multicenter study (topic); patient safety; patient satisfaction; pilot study; postoperative period; preoperative period; prospective study; prostate cancer; prostatectomy; quality of life; treatment outcome; tumor ablation; visual analog scale; ablation therapy; adenocarcinoma; clinical trial; cohort analysis; electroporation; multicenter study; nuclear magnetic resonance imaging; pathology; procedures; prostate; prostatectomy; Prostatic Neoplasms, Ablation Techniques; Adenocarcinoma; Cohort Studies; Electroporation; Humans; Magnetic Resonance Imaging; Male; Pilot Projects; Prospective Studies; Prostate; Prostatectomy; Prostatic Neoplasms
DOI:
10.1136/bmjopen-2014-006382
