eprintid: 1476567
rev_number: 30
eprint_status: archive
userid: 608
dir: disk0/01/47/65/67
datestamp: 2016-03-14 17:41:16
lastmod: 2021-12-13 02:26:41
status_changed: 2016-03-14 17:41:16
type: article
metadata_visibility: show
creators_name: Langley, RE
creators_name: Kynaston, HG
creators_name: Alhasso, AA
creators_name: Duong, T
creators_name: Paez, EM
creators_name: Jovic, G
creators_name: Scrase, CD
creators_name: Robertson, A
creators_name: Cafferty, F
creators_name: Welland, A
creators_name: Carpenter, R
creators_name: Honeyfield, L
creators_name: Abel, RL
creators_name: Stone, M
creators_name: Parmar, MK
creators_name: Abel, PD
title: A Randomised Comparison Evaluating Changes in Bone Mineral Density in Advanced Prostate Cancer: Luteinising Hormone-releasing Hormone Agonists Versus Transdermal Oestradiol
ispublished: inpress
divisions: UCL
divisions: B02
divisions: D65
divisions: J38
keywords: Androgen-deprivation therapy, Bone mineral density, Prostate cancer, Transdermal oestradiol
note: © 2015 European Association of Urology. Published by Elsevier B.V. This is an open access article under the CC BY
license (http://creativecommons.org/licenses/by/4.0/).
abstract: BACKGROUND: Luteinising hormone-releasing hormone agonists (LHRHa), used as androgen deprivation therapy (ADT) in prostate cancer (PCa) management, reduce serum oestradiol as well as testosterone, causing bone mineral density (BMD) loss. Transdermal oestradiol is a potential alternative to LHRHa. OBJECTIVE: To compare BMD change in men receiving either LHRHa or oestradiol patches (OP). DESIGN, SETTING, AND PARTICIPANTS: Men with locally advanced or metastatic PCa participating in the randomised UK Prostate Adenocarcinoma TransCutaneous Hormones (PATCH) trial (allocation ratio of 1:2 for LHRHa:OP, 2006-2011; 1:1, thereafter) were recruited into a BMD study (2006-2012). Dual-energy x-ray absorptiometry scans were performed at baseline, 1 yr, and 2 yr. INTERVENTIONS: LHRHa as per local practice, OP (FemSeven 100μg/24h patches). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was 1-yr change in lumbar spine (LS) BMD from baseline compared between randomised arms using analysis of covariance. RESULTS AND LIMITATIONS: A total of 74 eligible men (LHRHa 28, OP 46) participated from seven centres. Baseline clinical characteristics and 3-mo castration rates (testosterone ≤1.7 nmol/l, LHRHa 96% [26 of 27], OP 96% [43 of 45]) were similar between arms. Mean 1-yr change in LS BMD was -0.021g/cm(3) for patients randomised to the LHRHa arm (mean percentage change -1.4%) and +0.069g/cm(3) for the OP arm (+6.0%; p<0.001). Similar patterns were seen in hip and total body measurements. The largest difference between arms was at 2 yr for those remaining on allocated treatment only: LS BMD mean percentage change LHRHa -3.0% and OP +7.9% (p<0.001). CONCLUSIONS: Transdermal oestradiol as a single agent produces castration levels of testosterone while mitigating BMD loss. These early data provide further supporting evidence for the ongoing phase 3 trial. PATIENT SUMMARY: This study found that prostate cancer patients treated with transdermal oestradiol for hormonal therapy did not experience the loss in bone mineral density seen with luteinising hormone-releasing hormone agonists. Other clinical outcomes for this treatment approach are being evaluated in the ongoing PATCH trial. TRIAL REGISTRATION: ISRCTN70406718, PATCH trial (ClinicalTrials.gov NCT00303784).
date: 2015-12-17
date_type: published
official_url: http://dx.doi.org/10.1016/j.eururo.2015.11.030
oa_status: green
full_text_type: pub
language: eng
primo: open
primo_central: open_green
article_type_text: JOURNAL ARTICLE
verified: verified_manual
elements_id: 1096631
doi: 10.1016/j.eururo.2015.11.030
pii: S0302-2838(15)01201-4
language_elements: ENG
lyricists_name: Cafferty, Fay
lyricists_name: Duong, Trinh
lyricists_name: Langley, Ruth
lyricists_name: Parmar, Mahesh
lyricists_id: FCAFF86
lyricists_id: TNHDU52
lyricists_id: RELAN40
lyricists_id: MKBPA56
actors_name: Barczynska, Patrycja
actors_id: PBARC91
actors_role: owner
full_text_status: public
publication: European Urology
issn: 1873-7560
citation:        Langley, RE;    Kynaston, HG;    Alhasso, AA;    Duong, T;    Paez, EM;    Jovic, G;    Scrase, CD;                                     ... Abel, PD; + view all <#>        Langley, RE;  Kynaston, HG;  Alhasso, AA;  Duong, T;  Paez, EM;  Jovic, G;  Scrase, CD;  Robertson, A;  Cafferty, F;  Welland, A;  Carpenter, R;  Honeyfield, L;  Abel, RL;  Stone, M;  Parmar, MK;  Abel, PD;   - view fewer <#>    (2015)    A Randomised Comparison Evaluating Changes in Bone Mineral Density in Advanced Prostate Cancer: Luteinising Hormone-releasing Hormone Agonists Versus Transdermal Oestradiol.                   European Urology        10.1016/j.eururo.2015.11.030 <https://doi.org/10.1016/j.eururo.2015.11.030>.    (In press).    Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/1476567/1/1-s2.0-S0302283815012014-main.pdf