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Sponsored by: |
Imperial College London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303784 |
RATIONALE: Testosterone can cause the growth of prostate cancer cells. Hormone therapy using estrogen and luteinizing hormone-releasing hormone analog may fight prostate cancer by lowering the amount of testosterone the body makes. Giving estrogen in a skin patch may improve quality of life and help patients live more comfortably.
PURPOSE: This randomized phase II trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone analog in treating patients with locally advanced or metastatic prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Prostate Cancer |
Drug: releasing hormone agonist therapy Drug: transdermal estrogen |
Phase II |
Study Type: | Interventional |
Study Design: | Active Control, Randomized, Treatment |
Official Title: | Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | March 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms at 1(control):2 (patch) ratio.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
Newly diagnosed patients with any of the following:
Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the following:
PATIENT CHARACTERISTICS:
No cardiovascular disease, including any of the following:
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
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Helen Patterson, MD 44-122324-5151 ext. 2523 and 2 | |
Alexandra Healthcare NHS | Recruiting |
Redditch, Worcestershire, England, United Kingdom, B98 7UB | |
Contact: Contact Person 44-015-2750-3030 | |
Castle Hill Hospital | Recruiting |
East Yorkshire, England, United Kingdom, HU16 5JQ | |
Contact: Contact Person 44-1482-875-875 | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Paul D. Abel 44-20-8383-2268 | |
Derbyshire Royal Infirmary | Recruiting |
Derby, England, United Kingdom, DE1 2QY | |
Contact: Contact Person 44-1332-347-141 ext. 2407 | |
George Eliot Hospital | Recruiting |
Nuneaton, England, United Kingdom, CV10 7DJ | |
Contact: Contact Person 44-024-7635-1351 | |
Grantham and District Hospital | Recruiting |
Grantham, Lincolnshire, England, United Kingdom, NG31 8DG | |
Contact: P. Daruwala 44-1476-565-232 | |
Hillingdon Hospital | Recruiting |
Uxbridge, England, United Kingdom, UB8 3NN | |
Contact: Alvan J. Pope 44-1895-238-282 | |
Mayday University Hospital | Recruiting |
Croydon, England, United Kingdom | |
Contact: Robert A. Huddart, MD 44-20-8401-3000 | |
Ipswich Hospital | Recruiting |
Ipswich, England, United Kingdom, IP4 5PD | |
Contact: Christopher Scrase, MD 44-147-370-4177 | |
James Cook University Hospital | Recruiting |
Middlesbrough, England, United Kingdom, TS4 3BW | |
Contact: Contact Person 44-1642-850-850 | |
Kidderminster Hospital | Recruiting |
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ | |
Contact: Contact Person 44-190-576-0635 | |
Kings Mill Hospital | Recruiting |
Nottinghamshire, England, United Kingdom, NG17 4JL | |
Contact: Contact Person 44-162-362-2515 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Contact Person 44-113-206-6400 | |
Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Sharon Beesley 44-1622-729-000 | |
Hope Hospital | Recruiting |
Salford, England, United Kingdom, M6 8HD | |
Contact: Noel Clarke 44-161-206-5568 | |
Nottingham City Hospital NHS Trust | Recruiting |
Nottingham, England, United Kingdom, NG5 1PB | |
Contact: Santhanam Sundar 44-115-969-1169 santhanam.sundar@nuh.nhs.uk | |
Queen's Hospital | Recruiting |
Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
Contact: Contact Person 44-1283-566-333 | |
Royal Devon and Exeter Hospital | Recruiting |
Exeter, England, United Kingdom, EX2 5DW | |
Contact: Denise J. Sheehan, MD 44-1392-411-611 | |
Scarborough General Hospital | Recruiting |
Scarborough, England, United Kingdom, YO12 6QL | |
Contact: Andrew Robertson 44-1723-368-111 | |
Walsgrave Hospital | Recruiting |
Coventry, England, United Kingdom, CV2 2DX | |
Contact: Contact Person 44-24-7660-2020 | |
Stepping Hill Hospital | Recruiting |
Stockport, England, United Kingdom, SK2 7JE | |
Contact: Contact Person 44-161-483-1010 | |
Walsall Manor Hospital | Recruiting |
Walsall, England, United Kingdom, WS2 9PS | |
Contact: Contact Person 44-1922-721-172 | |
St. Mary's Hospital | Recruiting |
London, England, United Kingdom, W2 1NY | |
Contact: Simon Stewart, MD 44-207-886-1132 s.stewart@imperial.ac.uk | |
Warwick Hospital | Recruiting |
Warwick, England, United Kingdom, CV34 5BW | |
Contact: Contact Person 44-1926 495-321 | |
Worthing Hospital | Recruiting |
Worthing, England, United Kingdom, BN11 2DH | |
Contact: Ralph Beard 44-1903-205-111 ext. 5559 | |
Yeovil District Hospital | Recruiting |
Yeovil, England, United Kingdom, BA21 4AT | |
Contact: Chris Parker 44-1935-475-122 | |
Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting |
Crewe, England, United Kingdom, CW1 4QJ | |
Contact: J. P. Logue, MD 44-1270-255-141 | |
United Kingdom, Scotland | |
Ayr Hospital | Recruiting |
Ayr, Scotland, United Kingdom, KA6 6DX | |
Contact: Contact Person 44-1292-610-555 | |
Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G12 0YN | |
Contact: Contact Person 44-141-211-2123 | |
United Kingdom, Wales | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: J. Lester, MD 44-29-2031-6292 | |
University Hospital of Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Howard Kynaston 44-2920-745-094 |
Study Chair: | Paul D. Abel | Charing Cross Hospital |
Study ID Numbers: | CDR0000455583, EU-205106, EUDRACT-2005-001030-33, ISRCTN70406718, MRC-PATCH, MRC-PR09 |
Study First Received: | March 15, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00303784 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate anemia cardiovascular complications hot flashes |
osteoporosis recurrent prostate cancer stage III prostate cancer stage IV prostate cancer |
Estrogens Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Anemia Hot Flashes Hormones, Hormone Substitutes, and Hormone Antagonists |
Osteoporosis Urogenital Neoplasms Genital Diseases, Male Hormones Recurrence Adenocarcinoma Prostatic Neoplasms |
Estrogens Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Pharmacologic Actions |