A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy and hormonal recovery

Publication date: Available online 2 February 2018
Source:Brachytherapy
Author(s): M.A. Korzeniowski, J.M. Crook, D. Bowes, M. Gaztañaga, A. Ots, J. Jazwal, J. Rose, A. Tétreault-Laflamme, L. Pilote, R. Halperin, D. Kim, D. Petrik, C. Araujo, F. Bachand
PurposeThe purpose of this study was to determine the efficacy of 8 weeks of degarelix for prostate downsizing before interstitial brachytherapy. We also report associated toxicity and the time course of endocrine recovery over the following 12 months.Methods and MaterialsFifty patients were accrued to an open-label Phase II clinical trial (www.clinicaltrials.gov ID NCT01446991). Baseline prostate transrectal ultrasound (TRUS) was performed on all patients followed by degarelix administration and a repeat TRUS at Week 8. Brachytherapy was performed within 4 weeks of the 8-week TRUS for all patients who achieved suitable downsizing.ResultsThe median prostate volume was reduced from 65.0 cc (interquartile range [IQR]: 55.2–80.0 cc) to 48.2 cc at 8 weeks (IQR: 41.2–59.3 cc), representing a median decrease of 26.2% (IQR: 21–31%). Functional recovery of testosterone within an age-adjusted normal range occurred at a median of 34.1 weeks (IQR: 28.2–44.5 weeks) from the date of the final injection. Despite this recovery, follicle-stimulating hormone and luteinizing hormone levels remained abnormally elevated throughout 12 months. Quality-of-life implications are discussed.ConclusionsDegarelix is effective for prostate downsizing before prostate brachytherapy with a median volume decrease of 26.2% by 8 weeks. Despite the short course of treatment and eventual testosterone recovery, follicle-stimulating hormone and luteinizing hormone remain elevated beyond 12 months. Further investigation with randomized comparisons to other hormonal agents is warranted.



from #AlexandrosSfakianakis via Alexandros G.Sfakianakis on Inoreader http://ift.tt/2s21Ojj
via IFTTT