Focal cryoablation: a treatment option for unilateral low‐risk prostate cancer. (31st October 2013)

• Record Type: Journal Article
• Authors: Durand, Matthieu; Barret, Eric; Galiano, Marc; Rozet, François; Sanchez‐Salas, Rafael; Ahallal, Youness; Macek, Petr; Gaya, Jose‐Maria; Cerruti, Jennifer; Devilliers, Hervé; Loeffler, Joyce; Amiel, Jean; Vallancien, Guy; Cathelineau, Xavier
• Is Part Of: BJU international. Volume 113:Number 1(2014:Jan.)
• Page Start: 56
• Page End: 64
• Publication Date: 2013-10-31
• Subjects: Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.12370
• Languages: English
• ISSNs: 1464-4096

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bju12370-sec-0001" sec-type="section"> <title>Objectives</title> <p> <list id="bju12370-list-0001" list-type="bullet"> <list-item> <p>To assess oncological (biochemical and histological recurrence) and functional (urinary and potency) outcomes in patients with unilateral low‐risk organ‐confined prostate cancer (PCa) treated with focal cryoablation (FC).</p> </list-item> </list> </p> </sec> <sec id="bju12370-sec-0002" sec-type="section"> <title>Patients and Methods</title> <p> <list id="bju12370-list-0002" list-type="bullet"> <list-item> <p>From January 2009 to March 2012, patients with localized PCa who refused active surveillance were assigned to a FC protocol.</p> </list-item> <list-item> <p>This was a prospective, single‐arm cohort study. Inclusion criteria were: unilateral disease, clinical stage T1c to T2a, prostate‐specific antigen (PSA) concentration <10 ng/mL, low volume index lesion and Gleason score ≤6 (3+3). Hemi‐ablation was carried out using the Precise<sup>TM</sup> cryoablation system (Galil Medical, Inc., Arden Hills, MN, USA).</p> </list-item> <list-item> <p>Oncological (PSA values) and functional (International Prostate Symptom Score and International Index of Erectile Function (IIEF)‐5 score) outcomes were analysed at 3‐, 6‐ and 12‐month follow‐up.</p> </list-item> <list-item> <p>The primary endpoint for oncological efficacy, no cancer in ipsilateral side, was based on the 12‐month mandatory biopsy.</p> </list-item> </list> </p> </sec> <sec id="bju12370-sec-0003" sec-type="section"> <title>Results</title> <p> <list id="bju12370-list-0003" list-type="bullet"> <list-item> <p>A total of 48 consecutive patients with a mean age of 67 years were included. The median (interquartile range) follow‐up was 13.2 (7.4–26.5) months.</p> </list-item> <list-item> <p>Follow‐up prostate biopsies were negative for the treated lobe in 86% of patients.</p> </list-item> <list-item> <p>The mean PSA concentration dropped significantly at 3 months (by 55%) but did not correlate well with positive biopsy results.</p> </list-item> <list-item> <p>Urinary symptoms were unchanged. A slight decrease in the IIEF‐5 score was present at 3 months, but did not differ significantly from baseline at 6‐month follow‐up.</p> </list-item> <list-item> <p>There were 15% grade 1 and 4% grade 2 complications (Clavien classification).</p> </list-item> </list> </p> </sec> <sec id="bju12370-sec-0004" sec-type="section"> <title>Conclusions</title> <p> <list id="bju12370-list-0004" list-type="bullet"> <list-item> <p>Focal cryoablation is a low‐morbidity option in selected patients with low‐risk PCa.</p> </list-item> <list-item> <p>We showed PSA concentration to be an unreliable marker for monitoring FC and recommend a protocol of mandatory biopsies for follow‐up.</p> </list-item> <list-item> <p>A multicentre randomized controlled trial is necessary to confirm the low‐morbidity and the biopsy‐proven PCa cure rates.</p> </list-item> </list> </p> </sec> </abstract>