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Hormone Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2008
First Received: March 15, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: Imperial College London
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303784
  Purpose

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

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cardiovascular morbidity and mortality [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormone activity by castrate levels of hormones [ Designated as safety issue: No ]
  • Failure free survival [ Designated as safety issue: No ]
  • Other toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2006
Detailed Description:

OBJECTIVES:

Primary

  • Compare the cardiovascular system-related morbidity and mortality in patients with locally advanced or metastatic prostate cancer treated with transcutaneous estrogen patches vs luteinizing hormone-releasing hormone analogues.

Secondary

  • 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):2 (patch) ratio.

  • Arm I (control): Patients receive luteinizing hormone-releasing hormone analogues as per local practice in the absence of unacceptable toxicity.
  • Arm II (patch): Patients receive 3 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 2 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 20 months; and then every 6 months thereafter.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303784

Locations
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        
Sponsors and Collaborators
Imperial College London
Investigators
Study Chair: Paul D. Abel Charing Cross Hospital
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
anemia
cardiovascular complications
hot flashes
osteoporosis
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on March 16, 2009