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Phase II/III Randomized Pilot Study of Androgen Suppression (AS) Alone Versus AS in Varying Combinations With Zoledronate, Docetaxel, Prednisolone, and/or Celecoxib in Patients With Locally Advanced or Metastatic Prostate Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline 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
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III, Phase II | Treatment | Active | Not specified | MRC-STAMPEDE EU-205102, MRC-PR08, ISRCTN78818544, EUDRACT-2004-000193-31, NCT00268476 |
Objectives Primary - 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.
- 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 3300Approximately 3,300 patients will be accrued for this study. Outcomes Primary Outcome(s)Overall survival at 4 years
Secondary Outcome(s)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
Trial Contact Information
Trial Lead Organizations Medical Research Council Clinical Trials Unit ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Nicholas James, MD, Protocol chair | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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United Kingdom |
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England |
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Birmingham |
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| | | | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust |
| | Nicholas James, MD | |
| Email:
n.d.james@bham.ac.uk |
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Bournemouth |
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| | Royal Bournemouth Hospital NHS Trust |
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Brighton |
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| | Sussex Cancer Centre at Royal Sussex County Hospital |
| | Angus Robinson | |
| Email:
angus.robinson@bsuh.nhs.uk |
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Bristol |
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| | Bristol Haematology and Oncology Centre |
| | Amit Bahl, MD | |
| Email:
amit.bahl@ubht.nhs.uk |
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Broomfield |
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| | Broomfield Hospital |
| | Priscilla Leone, MD | |
| Email:
enca.parsons@meht.nhs.uk |
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Burton-upon-Trent |
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| | Queen's Hospital |
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Cottingham |
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| | Castle Hill Hospital |
| | J.W. Hetherington, MD | |
| Email:
jwhurologist@yahoo.co.uk |
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Derby |
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| | Derbyshire Royal Infirmary |
| | Prabir Chakraborti, MD | |
| Email:
prabir.chakraborti@derbyhospitals.nhs.uk |
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Durham |
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| | University Hospital of North Durham |
| | Rhona McMenemin | |
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Exeter |
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| | Royal Devon and Exeter Hospital |
| | Denise Sheehan, MD | |
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Guildford |
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| | St. Luke's Cancer Centre at Royal Surrey County Hospital |
| | Robert Laing, MD | |
| Email:
rlaing@royalsurrey.nhs.uk |
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Hereford |
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| | Hereford Hospitals NHS Trust |
| | Audrey Cook, MD | |
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Huddersfield, West Yorks |
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| | Huddersfield Royal Infirmary |
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Ipswich |
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| | Ipswich Hospital |
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Leeds |
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| | Leeds Cancer Centre at St. James's University Hospital |
| | Peter Whelan, MD | |
| Email:
peter.whelan@leedsth.nhs.uk |
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London |
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| | Guy's Hospital |
| | Rick Popert, MD | |
| Email:
rick.popert@gsst.nhs.uk |
| | University College of London Hospitals |
| | Stephen Harland, MD | |
| Email:
stephen.harland@uclh.nhs.uk |
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Maidstone |
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| | Mid Kent Oncology Centre at Maidstone Hospital |
| | Sharon Beelsey | |
| Email:
sbeesley@nhs.net |
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Manchester |
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| | Christie Hospital |
| | Noel Clarke | |
| | Withington Hospital |
| | Vijay Sangar, MD | |
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Merseyside |
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| | Clatterbridge Centre for Oncology |
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Middlesbrough |
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| | James Cook University Hospital |
| | John Hardman | |
| Email:
john.hardman@stees.nhs.uk |
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Northwood |
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| | Mount Vernon Cancer Centre at Mount Vernon Hospital |
| | Peter Hoskin, MD | |
| Email:
peterhoskin@nhs.net |
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Oxford |
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| | Churchill Hospital |
| | Andrew Protheroe, MD | |
| Email:
samantha.knipe@cancer.org.uk |
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Preston |
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| | Royal Preston Hospital |
| | Alison Birtle, MD | |
| Email:
alison.birtle@lthtr.nhs.uk |
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Salford |
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| | Hope Hospital |
| | Noel Clarke | |
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Sheffield |
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| | Cancer Research Centre at Weston Park Hospital |
| | Catherine Ferguson, MD | |
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Shrewsbury |
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| | Royal Shrewsbury Hospital |
| | Narayanan Srihari, MD | |
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Southampton |
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| | Southampton General Hospital |
| | Catherine Heath | |
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Stockport |
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| | Stepping Hill Hospital |
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Sunderland |
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| | Sunderland Royal Hospital |
| | Ian Pedley | |
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Sutton |
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| | Royal Marsden - Surrey |
| | David P. Dearnaley, MD, FRCP, FRCR | |
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Swindon |
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| | Great Western Hospital |
| | David Cole, MD | |
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Torquay |
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| | Torbay Hospital |
| | Anna Lydon, MD | |
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Westcliff-On-Sea |
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| | Southend University Hospital NHS Foundation Trust |
| | David Tsang, MD | |
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Worthing |
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| | Worthing Hospital |
| | Contact Person | Ph: | 44-1903-205-111 ext. 4225 | | |
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Northern Ireland |
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Belfast |
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| | | Centre for Cancer Research and Cell Biology at Queen's University Belfast |
| | Joe O'Sullivan | |
| Email:
joe.osullivan@qub.ack.uk |
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Scotland |
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Edinburgh |
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| | | Edinburgh Cancer Centre at Western General Hospital |
| | Duncan McLaren | |
| Email:
duncan.mclaren@luht.scot.nhs.uk |
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Glasgow |
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| | Beatson Institute for Cancer Research - Glasgow |
| | Contact Person | |
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Wales |
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Cardiff |
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| | | Velindre Cancer Center at Velindre Hospital |
| | Malcolm Mason, MD | |
| Email:
masonmd@cardiff.ac.uk |
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Swansea |
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| | South West Wales Cancer Institute |
| | Gianfilippo Bertelli, MD, FRCPE | |
| Email:
gianfilippo.bertelli@swansea-tr.wales.nhs.uk |
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Registry Information | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy [STAMPEDE] A 5-Stage Multi-Arm Randomized Controlled Trial | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2005-09-19 | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00268476 | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2005-09-29 | ![](https://webarchive.library.unt.edu/web/20090513100325im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-03-30 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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