PMID- 29398594
OWN - NLM
STAT- MEDLINE
DCOM- 20190206
LR  - 20190215
IS  - 1873-1449 (Electronic)
IS  - 1538-4721 (Linking)
VI  - 17
IP  - 3
DP  - 2018 May-Jun
TI  - A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy 
      and hormonal recovery.
PG  - 530-536
LID - S1538-4721(17)30574-3 [pii]
LID - 10.1016/j.brachy.2017.12.005 [doi]
AB  - 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 [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. 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.
CI  - Copyright (c) 2017 American Brachytherapy Society. Published by Elsevier Inc. All 
      rights reserved.
FAU - Korzeniowski, M A
AU  - Korzeniowski MA
AD  - Kingston Health Sciences, Queen's University, Kingston, Ontario, Canada.
FAU - Crook, J M
AU  - Crook JM
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada. Electronic address: jcrook@bccancer.bc.ca.
FAU - Bowes, D
AU  - Bowes D
AD  - Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada.
FAU - Gaztanaga, M
AU  - Gaztanaga M
AD  - Departmento Oncologia Radioterapia, Universidad Complutense Madrid, Madrid, 
      Spain.
FAU - Ots, A
AU  - Ots A
AD  - Clinical Oncology Department, United Lincolnshire Hospitals, Lincoln, UK.
FAU - Jazwal, J
AU  - Jazwal J
AD  - BC Cancer Agency, Surrey, British Columbia, Canada.
FAU - Rose, J
AU  - Rose J
AD  - BC Cancer Agency, Abbotsford Centre, Abbotsford, British Columbia, Canada.
FAU - Tetreault-Laflamme, A
AU  - Tetreault-Laflamme A
AD  - Centre Hospitalier Universitaire de Sherbrook, Sherbrook, British Columbia, 
      Canada.
FAU - Pilote, L
AU  - Pilote L
AD  - Centre Hospitalier Universitaire de Quebece, Quebec City, Quebec City, Canada.
FAU - Halperin, R
AU  - Halperin R
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada.
FAU - Kim, D
AU  - Kim D
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada.
FAU - Petrik, D
AU  - Petrik D
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada.
FAU - Araujo, C
AU  - Araujo C
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada.
FAU - Bachand, F
AU  - Bachand F
AD  - British Columbia Cancer Agency, Center for the Southern Interior, Kelowna, 
      British Columbia, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT01446991
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180202
PL  - United States
TA  - Brachytherapy
JT  - Brachytherapy
JID - 101137600
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Gonadotropins, Pituitary)
RN  - 0 (Oligopeptides)
RN  - 0 
      (acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide)
RN  - 33515-09-2 (Gonadotropin-Releasing Hormone)
RN  - 3XMK78S47O (Testosterone)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents, Hormonal/*administration & dosage/adverse effects
MH  - Brachytherapy/methods
MH  - Follow-Up Studies
MH  - Gonadotropin-Releasing Hormone
MH  - Gonadotropins, Pituitary/blood
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oligopeptides/*administration & dosage/adverse effects
MH  - Prostate/diagnostic imaging/*drug effects/pathology
MH  - Prostate-Specific Antigen
MH  - Prostatic Neoplasms/*drug therapy/radiotherapy
MH  - Quality of Life
MH  - Testosterone/blood
MH  - Treatment Outcome
MH  - Ultrasonography/methods
OTO - NOTNLM
OT  - Brachytherapy
OT  - Degarelix
OT  - Prostate neoplasms
OT  - Quality of life
OT  - Testosterone
EDAT- 2018/02/06 06:00
MHDA- 2019/02/07 06:00
CRDT- 2018/02/06 06:00
PHST- 2017/11/13 00:00 [received]
PHST- 2017/12/20 00:00 [revised]
PHST- 2017/12/20 00:00 [accepted]
PHST- 2018/02/06 06:00 [pubmed]
PHST- 2019/02/07 06:00 [medline]
PHST- 2018/02/06 06:00 [entrez]
AID - S1538-4721(17)30574-3 [pii]
AID - 10.1016/j.brachy.2017.12.005 [doi]
PST - ppublish
SO  - Brachytherapy. 2018 May-Jun;17(3):530-536. doi: 10.1016/j.brachy.2017.12.005. 
      Epub 2018 Feb 2.