Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Androgen Suppression Alone or Combined With Zoledronate, Docetaxel, Prednisolone, and/or Celecoxib in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

Basic Trial Information

Objectives

Primary

1. Compare the safety of androgen suppression (AS) alone vs AS in varying combinations with zoledronate, docetaxel, prednisolone, and celecoxib in patients with locally advanced or metastatic prostate cancer.
2. Compare failure-free survival and overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Diagnosis of locally advanced or metastatic adenocarcinoma of the prostate, meeting 1 of the following criteria:
  • High risk newly diagnosed disease, meeting 1 of the following criteria:
    • Histologically confirmed T3-4, N0, M0 disease with prostate-specific antigen (PSA) ≥ 40 ng/mL or Gleason sum score 8-10
    • Histologically confirmed disease with any T, N+, M0 OR any T, any N, M+
    • Multiple sclerotic bone metastases with a PSA ≥ 100 ng/mL without histological confirmation
  • Histologically confirmed previously treated disease with radical surgery or radiotherapy that is now relapsing AND meets 1 of the following criteria:
    • PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
    • PSA ≥ 20 ng/mL

• Intention to treat with long-term androgen suppression

• Testosterone normal (prior to the start of hormonal therapy)

• No metastatic brain disease or leptomeningeal disease

Prior/Concurrent Therapy:

• See Disease Characteristics
• Prior adjuvant or neoadjuvant hormonal therapy for localized disease must have been completed at least 12 months ago and have been no longer than 12 months in duration
• No prior cyclooxygenase-2 inhibitor therapy that lasted ≥ 6 months prior to study entry
• No surgery (e.g., transurethral resection of the prostate [TURP]) performed within the past 4 weeks
• No prior systemic therapy for locally advanced or metastatic prostate cancer
• No other concurrent cyclooxygenase-2 inhibitors
• No concurrent participation in another clinical trial for prostate cancer

Patient Characteristics:

• WHO performance status 0-2
• Neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• ALT or AST ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• Serum creatinine ≤ 1.5 times ULN
• No renal insufficiency with estimated creatinine clearance < 30 mL/min
• No severe congestive heart failure
• No history of severe/unstable angina
• No history of myocardial infarction
• No history of New York Heart Association class II-IV severe cardiac failure
• No history of cerebrovascular disease (e.g., stroke or transient ischemic episode)
• No symptomatic peripheral neuropathy ≥ grade 2
• No active peptic ulceration, gastrointestinal bleeding, or inflammatory bowel disease
• No other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with study treatment or assessment
• Willing and expected to comply with follow-up schedule

Expected Enrollment

Approximately 3,300 patients will be accrued for this study.

Outcomes

Overall survival at 4 years

Quality of life (QOL) by EORTC QOL Questionnaire C30 and prostate specific 25-item
Cost effectiveness by EuroQol
Failure-free survival
Toxicity
Skeletal related events

Outline

This is a randomized, controlled, multicenter, pilot study. Patients are randomized to 1 of 6 treatment arms.

• Arm I (androgen suppression [AS] only [control]): Patients undergo bilateral orchidectomy or receive luteinizing hormone-releasing hormone (LHRH) analogues to achieve castration levels of testosterone.

• Arm II (AS and zoledronate): Patients undergo AS as in arm I. Patients also receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 3 weeks for 6 courses and then every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

• Arm III (AS, docetaxel, and prednisolone): Patients undergo AS as in arm I. Patients also receive docetaxel IV over 1 hour on day 1 and oral prednisolone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

• Arm IV (AS and celecoxib): Patients undergo AS as in arm I. Patients also receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity.

• Arm V (AS, zoledronate, docetaxel, and prednisolone): Patients undergo AS as in arm I. Patients also receive zoledronate as in arm II and docetaxel and prednisolone as in arm III.

• Arm VI (AS, zoledronate, and celecoxib): Patients undergo AS as in arm I. Patients also receive zoledronate as in arm II and celecoxib as in arm IV.

After completion of study treatment, patients are followed periodically thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

James ND, Sydes MR, Clarke NW, et al.: Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. BJU Int 103 (4): 464-9, 2009.[PUBMED Abstract]

Sydes MR, Parmar MK, James ND, et al.: Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials 10: 39, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Nicholas James, MD, Protocol chair		Ph: 44-121-697-8314 Email: n.d.james@bham.ac.uk

Switzerland
	Aarau
	Hirslanden Klinik Aarau
		Contact Person	Ph:  41-62-836-7800
	Basel
	Universitaetsspital-Basel
		Contact Person	Ph:  41-61-265-2525
	Bern
	Inselspital Bern
		Contact Person	Ph:  41-31-632-2243
	Chur
	Kantonsspital Graubuenden
		Contact Person	Ph:  41-81-256-6111
	St. Gallen
	Kantonsspital - St. Gallen
		Contact Person	Ph:  41-71-494-1062
	Zurich
	City Hospital Triemli
		Contact Person	Ph:  41-1-466-1111
	UniversitaetsSpital Zuerich
		Contact Person	Ph:  41-44-255-1111
United Kingdom
England
	Ashford-Kent
	William Harvey Hospital
		Contact Person	Ph:  44-1233-633-331
	Aylesbury-Buckinghamshire
	Stoke Mandeville Hospital
		Contact Person	Ph:  44-1296-315-000
	Barnstaple
	North Devon District Hospital
		Contact Person	Ph:  44-1271-322-577
	Basingstoke
	Basingstoke and North Hampshire NHS Foundation Trust
		Contact Person	Ph:  44-125-631-4793
	Bath
	Royal United Hospital
		Contact Person	Ph:  44-1-225-824-042
	Birmingham
	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
		Nicholas James, MD	Ph:  44-121-697-8314
			Email: n.d.james@bham.ac.uk
	Bournemouth
	Royal Bournemouth Hospital
		Contact Person	Ph:  44-202-303-626
	Bradford
	Bradford Royal Infirmary
		Contact Person	Ph:  44-1274-542-200
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Angus Robinson	Ph:  44-127-369-6955
			Email: angus.robinson@bsuh.nhs.uk
	Bristol
	Bristol Haematology and Oncology Centre
		Amit Bahl, MD	Ph:  44-117-928-2468
			Email: amit.bahl@ubht.nhs.uk
	Broomfield
	Broomfield Hospital
		Priscilla Leone, MD	Ph:  44-1245-516-318
			Email: enca.parsons@meht.nhs.uk
	Burnley
	Burnley General Hospital
		Contact Person	Ph:  44-128-242-5071
	Burton-upon-Trent
	Queen's Hospital
		Contact Person	Ph:  44-1708-435-440
	Bury St. Edmunds
	West Suffolk Hospital
		Contact Person	Ph:  44-1284-713-000
	Canterbury
	Kent and Canterbury Hospital
		Contact Person	Ph:  44-1227-766-877
	Carlisle
	Cumberland Infirmary
		Contact Person	Ph:  44-1228-523-444
	Chester
	Countess of Chester Hospital
		Contact Person	Ph:  44-1244-365-000
	Cosham
	Queen Alexandra Hospital
		Contact Person	Ph:  44-23-9228-6000
	Cottingham
	Castle Hill Hospital
		J.W. Hetherington, MD	Ph:  44-1482-622183
			Email: jwhurologist@yahoo.co.uk
	Crewe
	Mid Cheshire Hospitals Trust- Leighton Hopsital
		Contact Person	Ph:  44-1270-255-141
	Darlington
	Darlington Memorial
		Contact Person	Ph:  44-1325-74-3222
	Derby
	Derbyshire Royal Infirmary
		Prabir Chakraborti, MD	Ph:  44-1322-347-141
			Email: prabir.chakraborti@derbyhospitals.nhs.uk
	Dorchester
	Dorset County Hospital
		Contact Person	Ph:  44-1305-251-150
	Dudley
	Russells Hall Hospital
		Contact Person	Ph:  44-1384-456-111
	Durham
	University Hospital of North Durham
		Rhona McMenemin	Ph:  44-191-256-3579
	Eastbourne
	Eastbourne District General Hospital
		Contact Person	Ph:  44-1323-417-400
	Essex
	Princess Alexandra Hospital
		Contact Person	Ph:  44-1279-444-455
	Exeter
	Royal Devon and Exeter Hospital
		Denise Sheehan, MD	Ph:  44-1392-402-114
	Farnworth
	Royal Bolton Hospital
		Contact Person	Ph:  44-120-439-0390
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Robert Laing, MD	Ph:  44-1483-571-112
			Email: rlaing@royalsurrey.nhs.uk
	Hereford
	Hereford Hospitals
		Audrey Cook, MD	Ph:  44-8454-222-871
	High Wycombe
	Wycombe General Hospital
		Contact Person	Ph:  44-1494-526-161
	Huddersfield, West Yorks
	Huddersfield Royal Infirmary
		Contact Person	Ph:  44-1484-342-999
	Ipswich
	Ipswich Hospital
		Contact Person	Ph:  44-1473-702-572
	Keighley
	Airedale General Hospital
		Contact Person	Ph:  44-1535-652-511
	Kidderminster Worcestershire
	Kidderminster Hospital
		Contact Person	Ph:  44-190-576-0635
	Lancanshire
	Royal Albert Edward Infirmary
		Contact Person	Ph:  44-1942-244-000
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Peter Whelan, MD	Ph:  44-113-206-4904
			Email: peter.whelan@leedsth.nhs.uk
	Leicester
	Glenfield Hospital
		Contact Person	Ph:  44-116-287-1471
	Liverpool
	Royal Liverpool University Hospital
		Contact Person	Ph:  44-151-706-2000
	London
	Charing Cross Hospital
		Contact Person	Ph:  44-20-8846-1234
	Guy's Hospital
		Rick Popert, MD	Ph:  44-20-7188-6794
			Email: rick.popert@gsst.nhs.uk
	Helen Rollason Cancer Care Centre at North Middlesex Hospital
		Contact Person	Ph:  44-20-8887-2000
	Queen Elizabeth Hospital - Woolwich
		Contact Person	Ph:  44-208-836-6000
	St. George's Hospital
		Contact Person	Ph:  44-208-672-1255
	St. Mary's Hospital
		Contact Person	Ph:  44-20-7886- 6666
	UCL Cancer Institute
		Contact Person	Ph:  44-20-7679-6697
	University College of London Hospitals
		Stephen Harland, MD	Ph:  44-207-380-9287
			Email: stephen.harland@uclh.nhs.uk
	Maidstone
	Mid Kent Oncology Centre at Maidstone Hospital
		Sharon Beelsey	Ph:  44-1622-225074
			Email: sbeesley@nhs.net
	Manchester
	Christie Hospital
		Noel Clarke	Ph:  44-161-446-3364
	Withington Hospital
		Vijay Sangar, MD	Ph:  44-161-217-4290
	Margate
	Queen Elizabeth The Queen Mother Hospital
		Contact Person	Ph:  44-1843-225-544
	Merseyside
	Clatterbridge Centre for Oncology
		Contact Person	Ph:  44-151-334-1155
	Middlesbrough
	James Cook University Hospital
		John Hardman	Ph:  44-1642-853-285
			Email: john.hardman@stees.nhs.uk
	Newcastle-Upon-Tyne
	Northern Centre for Cancer Treatment at Newcastle General Hospital
		Contact Person	Ph:  44-191-219-4200
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Peter Hoskin, MD	Ph:  44-1923-844-533
			Email: peterhoskin@nhs.net
	Nottingham
	Nottingham City Hospital
		Contact Person	Ph:  44-115-969-1169
	Oxford
	Churchill Hospital
		Andrew Protheroe, MD	Ph:  44-1865- 226-183
			Email: samantha.knipe@cancer.org.uk
	Poole Dorset
	Dorset Cancer Centre
		Contact Person	Ph:  44-1202-442-532
	Preston
	Rosemere Cancer Centre at Royal Preston Hospital
		Alison Birtle, MD	Ph:  44-1772-522-752
			Email: alison.birtle@lthtr.nhs.uk
	Reading
	Berkshire Cancer Centre at Royal Berkshire Hospital
		Contact Person	Ph:  44-118-322-7878
	Romford
	Queen's Hospital
		Contact Person	Ph:  44-845-130-4204
	Saint Leonards-on-Sea
	Conquest Hospital
		Contact Person	Ph:  44-1424-755-255
	Salford
	Hope Hospital
		Noel Clarke	Ph:  44-161-206-5568
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Catherine Ferguson, MD	Ph:  44-114-226-5077
	Shrewsbury
	Royal Shrewsbury Hospital
		Narayanan Srihari, MD	Ph:  44-1743-261656
	South Shields
	South Tyneside District Hospital
		Contact Person	Ph:  44-191-454-8888
	Southampton
	Southampton General Hospital
		Catherine Heath	Ph:  44-23-8079-4202
	Southport
	Southport and Formby District General Hospital
		Contact Person	Ph:  44-1704-547-471
	Stevenage
	Lister Hospital
		Contact Person	Ph:  44-1438-314-333
	Stockport
	Stepping Hill Hospital
		Contact Person	Ph:  44-161-419-5883
	Sunderland
	Sunderland Royal Hospital
		Ian Pedley	Ph:  44-191-256-3575
	Sutton
	Royal Marsden - Surrey
		David P. Dearnaley, MD, FRCP, FRCR	Ph:  44-20-8661-3271
	Swindon
	Great Western Hospital
		David Cole, MD	Ph:  44-1793-604-336
	Taunton
	Musgrove Park Hospital
		Contact Person	Ph:  44-1823-333-444
	Torquay
	Torbay Hospital
		Anna Lydon, MD	Ph:  44-1803-655-376
	Warrington
	Warrington Hospital NHS Trust
		Contact Person	Ph:  44-1925-635-911
	Westcliff-On-Sea
	Southend University Hospital NHS Foundation Trust
		David Tsang, MD	Ph:  44-1902-435-555
	Whitehaven
	West Cumberland Hospital
		Contact Person	Ph:  44-1946-693-181
	Worcester
	Worcester Royal Hospital
		Contact Person	Ph:  44-1905-763-333
	Worthing
	Worthing Hospital
		Contact Person	Ph:  44-1903-205-111 ext. 4225
Northern Ireland
	Belfast
	Centre for Cancer Research and Cell Biology at Queen's University Belfast
		Joe O'Sullivan	Ph:  44-28-9032-9241
			Email: joe.osullivan@queens-belfast.ac.uk
Scotland
	Ayr
	Ayr Hospital
		Contact Person	Ph:  44-1292-610-555
	Edinburgh
	Edinburgh Cancer Centre at Western General Hospital
		Duncan McLaren	Ph:  44-131-537-3269
			Email: duncan.mclaren@luht.scot.nhs.uk
	Glasgow
	Beatson Institute for Cancer Research - Glasgow
		Contact Person	Ph:  44-141-211-6369
	Inverness
	Raigmore Hospital
		Contact Person	Ph:  44-1463-704-000 ext. 4310
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Malcolm Mason, MD	Ph:  44-29-2031-6964
			Email: masonmd@cardiff.ac.uk
	Swansea
	South West Wales Cancer Institute
		Gianfilippo Bertelli, MD, FRCPE	Ph:  44-179-228-5826
			Email: gianfilippo.bertelli@swansea-tr.wales.nhs.uk

Registry Information
Official Title		Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy [STAMPEDE] A 5-Stage Multi-Arm Randomized Controlled Trial
Trial Start Date		2005-09-19
Registered in ClinicalTrials.gov		NCT00268476
Date Submitted to PDQ		2005-09-29
Information Last Verified		2008-03-30

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