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

作者：Korzeniowski M A; Crooke J M^*; Bowes D; Gaztanaga M; Ots A; Jazwal J; Rose J; Tetreault Laflamme A; Pilote L; Halperin R; Kim D; Petrik D; Araujo C; Bachand F

来源：Brachytherapy, 2018, 17(3): 530-536.

DOI：10.1016/j.brachy.2017.12.005

• Prostate neoplasms
• Degarelix
• Brachytherapy
• Testosterone
• Quality of life

PURPOSE: The 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 MATERIALS: Fifty 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.
RESULTS: The median prostate volume was reduced from 65.0 cc (interquartile range [IQRI: 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.
CONCLUSIONS: Degarelix 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.

• 出版日期2018-6