Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Hormone Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active Not specified Other MRC-PATCH EU-205106, MRC-PR09, ISRCTN70406718, EUDRACT-2005-001030-33, NCT00303784

Objectives

Primary

1. 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

1. Compare the activity of these treatments, in terms of castrate level of hormones, failure-free survival, and biochemical failure, in these patients.
2. Compare other toxicities, including osteoporosis, hot flushes, gynecomastia, and anemia, in patients treated with these regimens.
3. Compare the quality of life of patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 200 patients will be accrued for this study.

Outcomes

Cardiovascular morbidity and mortality

Hormone activity by castrate levels of hormones
Failure free survival
Other toxicity

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

Trial Contact Information

Trial Lead Organizations

Imperial College London

Paul Abel, Protocol chair		Ph: 44-20-8383-2268

United Kingdom
England
	Burton-upon-Trent
	Queen's Hospital
		Contact Person	Ph:  44-1283-566-333
	Cambridge
	Addenbrooke's Hospital
		Helen Patterson, MD	Ph:  44-122324-5151 ext. 2523 and 2525
	Coventry
	Walsgrave Hospital
		Contact Person	Ph:  44-24-7660-2020
	Crewe
	Mid Cheshire Hospitals Trust- Leighton Hopsital
		J. P. Logue, MD	Ph:  44-1270-255-141
	Croydon
	Mayday University Hospital
		Robert Huddart, MD	Ph:  44-20-8401-3000
	Derby
	Derbyshire Royal Infirmary
		Contact Person	Ph:  44-1332-347-141 ext. 2407
	East Yorkshire
	Castle Hill Hospital
		Contact Person	Ph:  44-1482-875-875
	Exeter
	Royal Devon and Exeter Hospital
		Denise Sheehan, MD	Ph:  44-1392-411-611
	Grantham, Lincolnshire
	Grantham and District Hospital
		P. Daruwala	Ph:  44-1476-565-232
	Ipswich
	Ipswich Hospital
		Christopher Scrase, MD	Ph:  44-147-370-4177
	Kidderminster Worcestershire
	Kidderminster Hospital
		Contact Person	Ph:  44-190-576-0635
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Contact Person	Ph:  44-113-206-6400
	London
	Charing Cross Hospital
		Paul Abel	Ph:  44-20-8383-2268
	St. Mary's Hospital
		Simon Stewart, MD	Ph:  44-207-886-1132
			Email: s.stewart@imperial.ac.uk
	Maidstone
	Maidstone Hospital
		Sharon Beesley	Ph:  44-1622-729-000
	Middlesbrough
	James Cook University Hospital
		Contact Person	Ph:  44-1642-850-850
	Nottingham
	Nottingham City Hospital NHS Trust
		Santhanam Sundar	Ph:  44-115-969-1169
			Email: santhanam.sundar@nuh.nhs.uk
	Nottinghamshire
	Kings Mill Hospital
		Contact Person	Ph:  44-162-362-2515
	Nuneaton
	George Eliot Hospital
		Contact Person	Ph:  44-024-7635-1351
	Redditch, Worcestershire
	Alexandra Healthcare NHS
		Contact Person	Ph:  44-015-2750-3030
	Salford
	Hope Hospital
		Noel Clarke	Ph:  44-161-206-5568
	Scarborough
	Scarborough General Hospital
		Andrew Robertson	Ph:  44-1723-368-111
	Stockport
	Stepping Hill Hospital
		Contact Person	Ph:  44-161-483-1010
	Uxbridge
	Hillingdon Hospital
		Alvan Pope	Ph:  44-1895-238-282
	Walsall
	Walsall Manor Hospital
		Contact Person	Ph:  44-1922-721-172
	Warwick
	Warwick Hospital
		Contact Person	Ph:  44-1926 495-321
	Worthing
	Worthing Hospital
		Ralph Beard	Ph:  44-1903-205-111 ext. 5559
	Yeovil
	Yeovil District Hospital
		Chris Parker	Ph:  44-1935-475-122
Scotland
	Ayr
	Ayr Hospital
		Contact Person	Ph:  44-1292-610-555
	Glasgow
	Beatson West of Scotland Cancer Centre
		Contact Person	Ph:  44-141-211-2123
Wales
	Cardiff
	University Hospital of Wales
		Howard Kynaston	Ph:  44-2920-745-094
	Velindre Cancer Center at Velindre Hospital
		J. Lester, MD	Ph:  44-29-2031-6292

Registry Information
Official Title		Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer
Trial Start Date		2006-03-07
Registered in ClinicalTrials.gov		NCT00303784
Date Submitted to PDQ		2005-10-06
Information Last Verified		2008-06-18

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