AnemiaPhase 3PATCHNCT00303784
Prostate Adenocarcinoma TransCutaneous Hormones
A Phase 3 study testing Goserelin and Estradiol in people with Anemia and Cardiovascular Complications, run by University College, London at 32 sites in United Kingdom.
Trial summary
RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be… Read more about this study
- Who is it for?
- Ages Up to 120 years, men only
- Conditions the study is for
- Anemia, Cardiovascular Complications, Hot Flashes
- What is being tested?
- Goserelin and Estradiol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 32 sitesUnited Kingdom
- Study dates
- Mar 2006to Aug 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Must meet 1 of the following criteria:
- Newly diagnosed patients with any of the following:
- Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) ≥ 20 ng/mL or Gleason score ≥ 6
- Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma
- Multiple sclerotic bone metastases with a PSA ≥ 50 ng/mL without histological confirmation
- Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the following:
- PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
- PSA ≥ 20 ng/mL
- Must have written informed consent
- Intention to treat with long-term androgen-deprivation therapy
- Normal testosterone level prior to hormonal treatment
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No other prior or current malignant disease or cardiovascular system disease that is likely to interfere with study treatment or assessment
- No cardiovascular disease, including any of the following:
- History of cerebral ischemia (e.g., stroke or transient ischemic attack) within the past 2 years
- History of deep vein thrombosis or pulmonary embolism confirmed radiologically
- History of myocardial infarction (MI) within the past 6 months OR MI more than 6 months ago with evidence of q-wave anterior infarct on ECG
- ECHO or MUGA required for patients with history of ischemic heart disease
- Left Ventricular Ejection Fraction ≤ 40%
- No condition or situation that could preclude protocol treatment or compliance with follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 12 months since prior adjuvant or neoadjuvant hormonal therapy for localized prostate cancer AND therapy lasted ≤ 12 months in duration
- No prior systemic therapy for locally advanced or metastatic prostate cancer
- No concurrent participation in another clinical trial of prostate cancer treatment that would preclude study therapy or outcome measures
- Concurrent prophylactic radiotherapy to prevent gynecomastia allowed
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United Kingdom32 sites, 32 recruiting
- Recruiting
Ayr Hospital
Ayr, Scotland, KA6 6DX
Contact Person, 44-1292-610-555
- Recruiting
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
Contact Person, 44-1283-566-333
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Helen Patterson, MD, 44-122324-5151 ext. 2523 and 2
- Recruiting
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
J. Lester, MD, 44-29-2031-6292
- Recruiting
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Howard Kynaston, 44-2920-745-094
- Recruiting
Walsgrave Hospital
Coventry, England, CV2 2DX
Contact Person, 44-24-7660-2020
- Recruiting
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ
J. P. Logue, MD, 44-1270-255-141
- Recruiting
Mayday University Hospital
Croydon, England
Robert A. Huddart, MD, 44-20-8401-3000
- Recruiting
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Contact Person, 44-1332-347-141 ext. 2407
- Recruiting
Castle Hill Hospital
East Yorkshire, England, HU16 5JQ
Contact Person, 44-1482-875-875
- Recruiting
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Denise J. Sheehan, MD, 44-1392-411-611
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Contact Person, 44-141-211-2123
- Recruiting
Grantham and District Hospital
Grantham, Lincolnshire, England, NG31 8DG
P. Daruwala, 44-1476-565-232
- Recruiting
Ipswich Hospital
Ipswich, England, IP4 5PD
Christopher Scrase, MD, 44-147-370-4177
- Recruiting
Kidderminster Hospital
Kidderminster Worcestershire, England, DY11 6RJ
Contact Person, 44-190-576-0635
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Contact Person, 44-113-206-6400
- Recruiting
St. Mary's Hospital
London, England, W2 1NY
Simon Stewart, MD, 44-207-886-1132, s.stewart@imperial.ac.uk
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
Paul D. Abel, 44-20-8383-2268
- Recruiting
Maidstone Hospital
Maidstone, England, ME16 9QQ
Sharon Beesley, 44-1622-729-000
- Recruiting
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Contact Person, 44-1642-850-850
- Recruiting
Nottingham City Hospital
Nottingham, England, NG5 1PB
Santhanam Sundar, 44-115-969-1169, santhanam.sundar@nuh.nhs.uk
- Recruiting
Kings Mill Hospital
Nottinghamshire, England, NG17 4JL
Contact Person, 44-162-362-2515
- Recruiting
George Eliot Hospital
Nuneaton, England, CV10 7DJ
Contact Person, 44-024-7635-1351
- Recruiting
Alexandra Healthcare NHS
Redditch, Worcestershire, England, B98 7UB
Contact Person, 44-015-2750-3030
- Recruiting
Hope Hospital
Salford, England, M6 8HD
Noel Clarke, 44-161-206-5568
- Recruiting
Scarborough General Hospital
Scarborough, England, YO12 6QL
Andrew Robertson, 44-1723-368-111
- Recruiting
Stepping Hill Hospital
Stockport, England, SK2 7JE
Contact Person, 44-161-483-1010
- Recruiting
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Alvan J. Pope, 44-1895-238-282
- Recruiting
Walsall Manor Hospital
Walsall, England, WS2 9PS
Contact Person, 44-1922-721-172
- Recruiting
Warwick Hospital
Warwick, England, CV34 5BW
Contact Person, 44-1926 495-321
- Recruiting
Worthing Hospital
Worthing, England, BN11 2DH
Ralph Beard, 44-1903-205-111 ext. 5559
- Recruiting
Yeovil District Hospital
Yeovil, England, BA21 4AT
Chris Parker, 44-1935-475-122
About this study
Official title: A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer
RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be associated with type II diabetes and increased cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but is not used routinely as first-line therapy because of the risk of cardiovascular system (CVS) complications. The CVS complications have been attributed to first-pass hepatic metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing testosterone to castrate levels. This hypothesis has been supported by results from the early stages of this trial which have provided sufficient indication of the safety and efficacy of the patches to warrant further investigation of the treatment in this setting, as recommended by the IDMC..
PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone agonist injections in treating patients with locally advanced or metastatic prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the progression-free survival and overall survival of patients with locally advanced or metastatic prostate cancer treated with transcutaneous estrogen patches vs luteinizing hormone-releasing hormone analogues.
Secondary
- Compare the cardiovascular system-related morbidity and mortality in patients treated with these regimens
- Compare the activity of these treatments, in terms of castrate level of hormones, failure-free survival, and biochemical failure, in these patients.
- Compare other toxicities, including osteoporosis, hot flushes, gynecomastia, and anemia, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms at 1(control):1 (patch) ratio.
- Arm I (control): Patients receive luteinizing hormone-releasing hormone agonists as per local practice in the absence of unacceptable toxicity.
- Arm II (patch): Patients receive 4 transcutaneous estrogen patches, changing twice weekly for 4 weeks. Patients' testosterone levels are measured at week 4. Patients whose testosterone level is > 1.7 nmol/L continue to receive patch as before and have their testosterone level measured every 2 weeks. Patients whose testosterone level is < 1.7 nmol/L at week 4 or any other point receive 3 transcutaneous estrogen patches changed twice weekly in the absence of unacceptable toxicity.
Quality of life is assessed at baseline; at weeks 4, 8, and 12; every 3 months for 24 months.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2200 patients will be accrued for this study.
- Conditions
- Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer
- Being tested
- Goserelin, Estradiol
- Keywords
- hot flashes, anemia, osteoporosis, cardiovascular complications, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Anemia, Hot Flashes, Osteoporosis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
Also called Zoladex
3.6mg implant, in pre-filled syringe
EstradiolDrug
Also called FemSeven
Each patch contains 3 mg of estradiol hemihydrate in a patch size of 30 cm2, releasing 100 micrograms of estradiol per 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| LHRH agonists | Active comparator | Patients randomised to the control arm will receive continuous treatment with LHRH agonists as per local practice. Treatment should continue for at least 3 years. LHRH antagonists, such as degarelix, are not allowed on the trial. The recommended "anti-flare" medication is bicalutamide and should be prescribed according to local practice. Control arm medication should be obtained from the hospital pharmacy or GP as per local practice. Receives: Drug: Goserelin |
| Oestrogen Patches | Experimental | Patients randomised to the investigational arm will receive transcutaneous oestrogen patches (100 micrograms/24 hours). Treatment should be planned to continue for at least 3 years. For patients prescribed bicalutamide or flutamide prior to randomisation, this treatment should be discontinued before treatment with the patches can commence (no washout period is needed). Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: Up to 180 months
Overall Survival
Measured: Up to 180 months
Secondary outcomes (5)
Hormone activity by castrate levels of hormones
Measured: Up to 180 months
Other toxicity
Measured: Up to 180 months
Cardiovascular morbidity
Measured: Up to 180 months
Cardiovascular mortality
Measured: Up to 180 months
Quality of Life
will be measured using patient-completed questionnaires, EORTC QLQ-C30 and PR25 which is prostate specific
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Paul D. Abel, Study chair, Charing Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303784
- Sponsor's protocol ID
- CDR0000455583
- Other IDs
- MRC-PATCH, EU-205106, MRC-PR09, ISRCTN70406718, 2005-001030-33, 2005
- Acronym
- PATCH
- Status last verified
- Nov 2020
- First submitted
- 15 Mar 2006
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langley RE, Gilbert DC, Mangar S, Rosen S, Bourmaki E, Rush HL, Kananga Sundaram S, Alhasso A, Kockelbergh R, Abdel-Aty H, Amos CL, Brown L, Brown S, Carvalho C, Chan K, Collins G, Cross W, Deighan J, Dixit S, Duong T, Dyer J, Gale J, Gillessen S, Griffiths A, Laniado M, Lydon A, McPhail N, MacNair A, Madaan S, Marshall J, Matheson D, Millman R, Mohamed W, Murphy L, Narahari K, Parker C, Panades M, Pope A, Raval A, Robinson A, Russell M, Scrase C, Sydes M, Turo R, Venkitaraman R, Wade S, Kynaston H, Attard G, James ND, Clarke N, Parmar MK, Nankivell M; STAMPEDE-1 and PATCH Investigators. Transdermal Estradiol Patches in Locally Advanced Prostate Cancer. N Engl J Med. 2026 Apr 23;394(16):1595-1607. doi: 10.1056/NEJMoa2511781. Epub 2026 Mar 25.
PubMed 41880608Gilbert DC, Nankivell M, Rush H, Clarke NW, Mangar S, Al-Hasso A, Rosen S, Kockelbergh R, Sundaram SK, Dixit S, Laniado M, McPhail N, Shaheen A, Brown S, Gale J, Deighan J, Marshall J, Duong T, Macnair A, Griffiths A, Amos CL, Sydes MR, James ND, Parmar MKB, Langley RE. 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. Clin Oncol (R Coll Radiol). 2024 Jan;36(1):e11-e19. doi: 10.1016/j.clon.2023.10.054. Epub 2023 Nov 8.
PubMed 37973477Gilbert DC, Duong T, Sydes M, Bara A, Clarke N, Abel P, James N, Langley R, Parmar M; STAMPEDE and PATCH Trial Management Groups. Transdermal oestradiol as a method of androgen suppression for prostate cancer within the STAMPEDE trial platform. BJU Int. 2018 May;121(5):680-683. doi: 10.1111/bju.14153. Epub 2018 Feb 28. No abstract available.
PubMed 29388336Langley 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. A Randomised Comparison Evaluating Changes in Bone Mineral Density in Advanced Prostate Cancer: Luteinising Hormone-releasing Hormone Agonists Versus Transdermal Oestradiol. Eur Urol. 2016 Jun;69(6):1016-25. doi: 10.1016/j.eururo.2015.11.030. Epub 2015 Dec 17.
PubMed 26707868Langley RE, Cafferty FH, Alhasso AA, Rosen SD, Sundaram SK, Freeman SC, Pollock P, Jinks RC, Godsland IF, Kockelbergh R, Clarke NW, Kynaston HG, Parmar MK, Abel PD. Cardiovascular outcomes in patients with locally advanced and metastatic prostate cancer treated with luteinising-hormone-releasing-hormone agonists or transdermal oestrogen: the randomised, phase 2 MRC PATCH trial (PR09). Lancet Oncol. 2013 Apr;14(4):306-16. doi: 10.1016/S1470-2045(13)70025-1. Epub 2013 Mar 4.
PubMed 23465742