Evidence map›Paper›PMID 37973477›Full record

Trial reportClinical oncology (Royal College of Radiologists (Great Britain))2024

A Repurposing Programme Evaluating Transdermal Oestradiol Patches for the Treatment of Prostate Cancer Within the PATCH and STAMPEDE Trials: Current Results and Adapting Trial Design.

D C Gilbert, M Nankivell, H Rush, N W Clarke, S Mangar, A Al-Hasso, S Rosen, R Kockelbergh, S K Sundaram, S Dixit and 15 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIAdaptive Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical oncology (Royal College of Radiologists (Great Britain)), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
3.6field-weighted citation impact, top 6% 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.

NCT00268476 phase2 / phase3active not recruitingnot on this map

STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial

TypeinterventionalSponsorMedical Research CouncilRan2005 to 2030Enrolled11,992ConditionsProstate CancerArmsCelecoxib, Docetaxel, Prednisolone, ADT, Zoledronic Acid
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

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 12 institutions in 2 countries.

D C GilbertMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK; University Hospitals Sussex NHS Foundation Trust, Royal Sussex County Hospital, Brighton, UK. Electronic address: duncan.gilbert@ucl.ac.uk.
M NankivellMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
H RushMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
N W ClarkeThe Christie and Salford Royal Hospitals, Manchester, UK.
S MangarCharing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
A Al-HassoBeatson West of Scotland Cancer Centre, Glasgow, UK.
S RosenNational Heart and Lung Institute, Imperial College, London, UK.
R KockelberghDepartment of Urology, University Hospitals of Leicester, Leicester, UK.
S K SundaramMid-Yorkshire Teaching NHS Trust, Pinderfields Hospital, Wakefield, UK.
S DixitScunthorpe General Hospital, Scunthorpe, UK.
M LaniadoWexham Park Hospital, Slough, UK.
N McPhailRaigmore Hospital, Inverness, UK.
A ShaheenSingleton Hospital, Swansea, UK.
S BrownAiredale General Hospital, Keighley, UK.
J GaleQueen Alexandra Hospital, Portsmouth, UK.
J DeighanPatient Representative, MRC Clinical Trials Unit at UCL, London, UK.
J MarshallMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
T DuongMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
A MacnairMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK; Guys and St Thomas' NHS Foundation Trust, London, UK.
A GriffithsMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
C L AmosMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
M R SydesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
N D JamesInstitute of Cancer Research, Sutton, UK.
M K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
R E LangleyMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK.
MRC Clinical Trials Unit at UCL · GBAiredale General Hospital · GBInstitute of Cancer Research · GBRoyal Sussex County Hospital · GBSingleton Hospital · GBBeatson West of Scotland Cancer Centre · GBGuy's and St Thomas' NHS Foundation Trust · GBQueen Alexandra Hospital · GBRaigmore Hospital · GBScunthorpe General Hospital · GBUniversity Hospitals of Leicester NHS Trust · GBWexham Park Hospital · GB

Funding

Cancer Research UK 12443Medical Research Council MC_UU_12023/25
6 · The paper itself

Abstract

aimsAndrogen deprivation therapy (ADT), usually achieved with luteinising hormone releasing hormone analogues (LHRHa), is central to prostate cancer management. LHRHa reduce both testosterone and oestrogen and are associated with significant long-term toxicity. Previous use of oral oestrogens as ADT was curtailed because of cardiovascular toxicity. Transdermal oestrogen (tE2) patches are a potential alternative ADT, supressing testosterone without the associated oestrogen-depletion toxicities (osteoporosis, hot flushes, metabolic abnormalities) and avoiding cardiovascular toxicity, and we here describe their evaluation in men with prostate cancer. MATERIALS AND

methodsThe PATCH (NCT00303784) adaptive trials programme (incorporating recruitment through the STAMPEDE [NCT00268476] platform) is evaluating the safety and efficacy of tE2 patches as ADT for men with prostate cancer. An initial randomised (LHRHa versus tE2) phase II study (n = 251) with cardiovascular toxicity as the primary outcome measure has expanded into a phase III evaluation. Those with locally advanced (M0) or metastatic (M1) prostate cancer are eligible. To reflect changes in both management and prognosis, the PATCH programme is now evaluating these cohorts separately.

resultsRecruitment is complete, with 1362 and 1128 in the M0 and M1 cohorts, respectively. Rates of androgen suppression with tE2 were equivalent to LHRHa, with improved metabolic parameters, quality of life and bone health indices (mean absolute change in lumbar spine bone mineral density of -3.0% for LHRHa and +7.9% for tE2 with an estimated difference between arms of 9.3% (95% confidence interval 5.3-13.4). Importantly, rates of cardiovascular events were not significantly different between the two arms and the time to first cardiovascular event did not differ between treatment groups (hazard ratio 1.11, 95% confidence interval 0.80-1.53; P = 0.54). Oncological outcomes are awaited. FUTURE: Efficacy results for the M0 cohort (primary outcome measure metastases-free survival) are expected in the final quarter of 2023. For M1 patients (primary outcome measure - overall survival), analysis using restricted mean survival time is being explored. Allied translational work on longitudinal samples is underway.

Indexed as

Prostatic NeoplasmsAndrogen AntagonistsAndrogensEstradiolEstrogensHumansMaleQuality of LifeTestosteroneAndrogen AntagonistsAndrogensEstradiolEstrogensTestosteroneAdaptive trialsandrogen deprivation therapyprostate cancertransdermal oestrogens

Identifiers

PMID37973477
PMCPMC7617162
OpenAlexW4388499610

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.