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Focal cryoablation: a treatment option for unilateral low‐risk prostate cancer
Author(s) -
Durand Matthieu,
Barret Eric,
Galiano Marc,
Rozet François,
SanchezSalas Rafael,
Ahallal Youness,
Macek Petr,
Gaya JoseMaria,
Cerruti Jennifer,
Devilliers Hervé,
Loeffler Joyce,
Amiel Jean,
Vallancien Guy,
Cathelineau Xavier
Publication year - 2014
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12370
Subject(s) - medicine , cryoablation , prostate cancer , prostate , interquartile range , urology , international prostate symptom score , stage (stratigraphy) , prospective cohort study , biopsy , cancer , surgery , lower urinary tract symptoms , ablation , paleontology , biology
Objectives 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 ).Patients and Methods From J anuary 2009 to M arch 2012, patients with localized PCa who refused active surveillance were assigned to a FC protocol. This was a prospective, single‐arm cohort study. Inclusion criteria were: unilateral disease, clinical stage T 1c to T 2a, prostate‐specific antigen ( PSA ) concentration <10 ng/mL, low volume index lesion and G leason score ≤6 (3+3). Hemi‐ablation was carried out using the Precise TM cryoablation system (Galil Medical, Inc., Arden Hills, MN, USA). 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. The primary endpoint for oncological efficacy, no cancer in ipsilateral side, was based on the 12‐month mandatory biopsy.Results 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. Follow‐up prostate biopsies were negative for the treated lobe in 86% of patients. The mean PSA concentration dropped significantly at 3 months (by 55%) but did not correlate well with positive biopsy results. 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. There were 15% grade 1 and 4% grade 2 complications ( C lavien classification).Conclusions Focal cryoablation is a low‐morbidity option in selected patients with low‐risk PCa . We showed PSA concentration to be an unreliable marker for monitoring FC and recommend a protocol of mandatory biopsies for follow‐up. A multicentre randomized controlled trial is necessary to confirm the low‐morbidity and the biopsy‐proven PCa cure rates.