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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Are there results?
None posted in the registry

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

  • 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

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT00303784
Study groupRoleWhat they receive
LHRH agonistsActive comparatorPatients 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 PatchesExperimentalPatients 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.

  1. Progression-Free Survival

    Measured: Up to 180 months

  2. Overall Survival

    Measured: Up to 180 months

Secondary outcomes (5)

  1. Hormone activity by castrate levels of hormones

    Measured: Up to 180 months

  2. Other toxicity

    Measured: Up to 180 months

  3. Cardiovascular morbidity

    Measured: Up to 180 months

  4. Cardiovascular mortality

    Measured: Up to 180 months

  5. 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.

  1. First posted17 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionAug 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

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)
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 41880608

  • Gilbert 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 37973477

  • Gilbert 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 29388336

  • 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. 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 26707868

  • Langley 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: Up to 180 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303784, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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