OBJECTIVES: To assess oncological (biochemical and histological recurrence) and functional (urinary and potency) outcomes in patients with unilateral low-risk organ-confined PCa treated with focal cryoablation.
PATIENTS AND METHODS: From January 2009 to March 2012, patients with localized prostate cancer who refused active surveillance were assigned to a focal cryoablation protocol. This was a prospective, single-arm cohort study. Inclusion criteria were: unilateral disease, clinical stage of T1c to T2a, PSA value < 10 ng/ml, low volume index lesion, Gleason score ≤ 6 (3+3). Hemi-ablation was carried out with the PreciseTM cryoablation system. Oncological (PSA) and functional (IPSS & IEFF-5 scores) outcomes were analysed at 3, 6 and 12-month follow-up. The primary endpoint for oncological efficacy was based on 12-month mandatory biopsy (no cancer in ipsilateral side).
RESULTS: 48 consecutive patients with a mean age of 67 were included. Median follow-up was 13.2 months (IQR: 7.4-26.5). Follow up prostate biopsies were negative for the treated lobe in 86%. The mean PSA value dropped significantly at 3 months (- 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 months follow up. There were 15% grade 1 and 4% grade 2 complications (Clavien classification).
CONCLUSIONS: Focal cryoablation is a low-morbidity option in selected patients with low-risk PCa. We showed PSA to be an unreliable marker for monitoring FC and recommend protocol-mandatory biopsies for follow up. A multicentre randomized-controlled trial is necessary to confirm the low-morbidity and the biopsy-proven PCa kill rates.
Written by:
Durand M, Barret E, Galiano M, Rozet F, Sanchez-Salas R, Ahallal Y, Macek P, Gaya JM, Cerruti J, Devilliers H, Loeffler J, Amiel J, Vallancien G, Cathelineau X. Are you the author?
Department of Urology, Institut Montsouris-Université Paris-Descartes, Paris; Department of Urology, Centre Hospitalier Universitaire de Nice, Hôpital de l'Archet 2, Nice.
Reference: BJU Int. 2013 Jul 19. Epub ahead of print.
doi: 10.1111/bju.12370
PubMed Abstract
PMID: 24053685
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