Evidence map›Paper›PMID 26707868›Full record

Trial reportEuropean urology2016

A Randomised Comparison Evaluating Changes in Bone Mineral Density in Advanced Prostate Cancer: Luteinising Hormone-releasing Hormone Agonists Versus Transdermal Oestradiol.

Ruth E Langley, Howard G Kynaston, Abdulla A Alhasso, Trinh Duong, Edgar M Paez, Gordana Jovic, Christopher D Scrase, Andrew Robertson, Fay Cafferty, Andrew Welland and 6 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00303784 (A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00303784 phase3unknown statusnot on this map

A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer

TypeinterventionalSponsorUniversity College, LondonRan2006 to 2021Enrolled2,200ConditionsAnemia, Cardiovascular Complications, Hot Flashes, OsteoporosisArmsGoserelin, Estradiol
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Incorporating Biomarker Stratification into STAMPEDE: an Adaptive Multi-arm, Multi-stage Trial Platform.Clinical oncology (Royal College of Radiologists (Great Britain)) · 2017
    Review
  11. The resurgence of estrogens in the treatment of castration-resistant prostate cancer.Indian journal of urology : IJU : journal of the Urological Society of India
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Ruth E LangleyMedical Research Council Clinical Trials Unit at University College London, London, UK. Electronic address: ruth.langley@ucl.ac.uk.
Howard G KynastonCardiff School of Medicine, Cardiff University, Cardiff, UK.
Abdulla A AlhassoThe Beatson West of Scotland Cancer Centre, Glasgow, UK.
Trinh DuongMedical Research Council Clinical Trials Unit at University College London, London, UK.
Edgar M PaezFreeman Hospital, Newcastle upon Tyne, UK.
Gordana JovicMedical Research Council Clinical Trials Unit at University College London, London, UK.
Christopher D ScraseIpswich Hospital NHS Trust, Ipswich, UK.
Andrew RobertsonScarborough General Hospital, Scarborough, UK.
Fay CaffertyMedical Research Council Clinical Trials Unit at University College London, London, UK.
Andrew WellandMedical Research Council Clinical Trials Unit at University College London, London, UK.
Robin CarpenterMedical Research Council Clinical Trials Unit at University College London, London, UK.
Lesley HoneyfieldImperial College Healthcare NHS Trust, London, UK.
Richard L AbelImperial College London, London, UK.
Michael StoneCardiff University, Bone Research Unit, Penarth, UK.
Mahesh K B ParmarMedical Research Council Clinical Trials Unit at University College London, London, UK.
Paul D AbelImperial College Healthcare NHS Trust, London, UK; Imperial College London, London, UK.
Medical Research Council · GBCardiff University · GBImperial College Healthcare NHS Trust · GBUniversity College London · GBBeatson West of Scotland Cancer Centre · GBFreeman Hospital · GBImperial College London · GBIpswich Hospital · GBScarborough General Hospital · GB

Funding

Cancer Research UK 12443Medical Research Council MC_UU_12023/28
6 · The paper itself

Abstract

backgroundLuteinising 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.

objectiveTo compare BMD change in men receiving either LHRHa or oestradiol patches (OP). DESIGN, SETTING, AND

participantsMen 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.

interventionsLHRHa 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).

conclusionsTransdermal 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 registrationISRCTN70406718, PATCH trial (ClinicalTrials.gov NCT00303784).

Indexed as

Absorptiometry, PhotonAdenocarcinomaAdministration, CutaneousAgedAged, 80 and overAndrogen AntagonistsBone DensityEstradiolFemur HeadGonadotropin-Releasing HormoneHumansLumbar VertebraeMaleProstatic NeoplasmsTestosteroneTransdermal PatchAndrogen AntagonistsEstradiolGonadotropin-Releasing HormoneTestosteroneAndrogen-deprivation therapyBone mineral densityProstate cancerTransdermal oestradiol

Identifiers

PMID26707868
PMCPMC4854173
OpenAlexW2219328805

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.