Last updated on February 2018

Prostate Adenocarcinoma TransCutaneous Hormones


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT00303784

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Queen's Hospital
Burton-upon-Trent, United Kingdom
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Helen Patterson, MD

Addenbrooke's Hospital
Cambridge, United Kingdom
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Walsgrave Hospital
Coventry, United Kingdom
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J. P. Logue, MD

Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, United Kingdom
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Robert A. Huddart, MD

Mayday University Hospital
Croydon, United Kingdom
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Derbyshire Royal Infirmary
Derby, United Kingdom
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Castle Hill Hospital
East Yorkshire, United Kingdom
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Denise J. Sheehan, MD

Royal Devon and Exeter Hospital
Exeter, United Kingdom
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P. Daruwala

Grantham and District Hospital
Grantham, Lincolnshire, United Kingdom
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Christopher Scrase, MD

Ipswich Hospital
Ipswich, United Kingdom
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Kidderminster Hospital
Kidderminster Worcestershire, United Kingdom
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Leeds Cancer Centre at St. James's University Hospital
Leeds, United Kingdom
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Simon Stewart, MD

St. Mary's Hospital
London, United Kingdom
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Paul D. Abel

Charing Cross Hospital
London, United Kingdom
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Sharon Beesley

Maidstone Hospital
Maidstone, United Kingdom
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James Cook University Hospital
Middlesbrough, United Kingdom
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Kings Mill Hospital
Nottinghamshire, United Kingdom
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Santhanam Sundar

Nottingham City Hospital
Nottingham, United Kingdom
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George Eliot Hospital
Nuneaton, United Kingdom
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Alexandra Healthcare NHS
Redditch, Worcestershire, United Kingdom
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Noel Clarke

Hope Hospital
Salford, United Kingdom
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Andrew Robertson

Scarborough General Hospital
Scarborough, United Kingdom
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Stepping Hill Hospital
Stockport, United Kingdom
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Alvan J. Pope

Hillingdon Hospital
Uxbridge, United Kingdom
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Walsall Manor Hospital
Walsall, United Kingdom
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Warwick Hospital
Warwick, United Kingdom
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Ralph Beard

Worthing Hospital
Worthing, United Kingdom
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Chris Parker

Yeovil District Hospital
Yeovil, United Kingdom
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Ayr Hospital
Ayr, United Kingdom
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Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
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J. Lester, MD

Velindre Cancer Center at Velindre Hospital
Cardiff, United Kingdom
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Howard Kynaston

University Hospital of Wales
Cardiff, United Kingdom
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