- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00316927
Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
A Randomized Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate - Immediate Versus Deferred Diethylstilbestrol
RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given together with two different schedules of diethylstilbestrol to compare how well they work in treating patients with locally advanced or metastatic prostate cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Compare the prostate-specific antigen (PSA) response in patients with locally advanced or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs immediate diethylstilbestrol.
Secondary
- Compare the overall response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-3), prostate-specific antigen (PSA) response to prior therapy (PSA normalization vs inability to normalize), and bone scan (positive vs negative for bony metastases). Patients are randomized to 1 of 2 treatment arms.
- Arm I (deferred diethylstilbestrol): Patients receive oral dexamethasone and oral acetylsalicyclic acid once daily (DA). Subsequent to treatment failure with DA, patients continue to receive DA as before in addition to oral diethylstilbestrol once daily (DAS). Treatment with DAS continues in the absence of disease progression or unacceptable toxicity.
- Arm II (immediate diethylstilbestrol): Patients receive oral dexamethasone, oral acetylsalicyclic acid, and oral diethylstilbestrol once daily (DAS). Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is evaluated monthly during study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
England
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Bristol, England, United Kingdom, BS2 8ED
- Bristol Haematology and Oncology centre
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Burnley, England, United Kingdom, BB10 2PQ
- Burnley General Hospital
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Canterbury, England, United Kingdom, CT2 3NG
- Kent and Canterbury Hospital
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Eastbourne, England, United Kingdom, BN21 2UD
- Eastbourne District General Hospital
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London, England, United Kingdom, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, United Kingdom, E11 1NR
- Whipps Cross Hospital
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London, England, United Kingdom, SW10 9NH
- Chelsea Westminster Hospital
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Maidstone, England, United Kingdom, ME16 9QQ
- Maidstone Hospital
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Milton Keynes, England, United Kingdom, MK6 5LD
- Milton Keynes General Hospital
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Oxford, England, United Kingdom, OX3 7LJ
- Churchill Hospital
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Romford, England, United Kingdom, RM7 OBE
- Oldchurch Hospital
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Torquay Devon, England, United Kingdom, TQ2 7AA
- Torbay Hospital
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Weston-super-Mare, England, United Kingdom, BS23 4TQ
- Weston General Hospital
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Worthing, England, United Kingdom, BN11 2DH
- Worthing Hospital
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York, England, United Kingdom, Y031 8HE
- Cancer Care Centre at York Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the prostate
- Elevated prostate-specific antigen (PSA)
- Failed previous treatments, including gonadatropan regulatory hormone analogue therapy, radiotherapy, surgery, or any combination of these
- Biochemically castrate (testosterone < 1 nmol/L) at baseline
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 months
- ECOG performance status 0-3
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count (neutrophils and bands) ≥ 2,000/mm^3
- Platelet count ≥ 50,000/mm^3
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST or ALT ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Able to swallow tablets
- No other malignancy within the past 3 years except basal cell skin cancer
No previous thromboembolic disease, including stroke, venous or arterial thrombosis, and myocardial infarction with ongoing angina pectoris
- Prior uncomplicated myocardial infarction allowed
- No diabetes mellitus if treatment titration is thought to be difficult or inappropriate
- No active gastric or duodenal ulcer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior concurrent bisphosphonates allowed
- No concurrent investigational agents or participation in another investigational drug study
- No other concurrent antineoplastic therapy, including new estrogen therapy, radiation therapy, or PC-SPES
- No other concurrent corticosteroids (e.g., dexamethasone for nausea or vomiting) except those prescribed in the study regimen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Prostate-specific antigen (PSA) response
|
Secondary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Overall response
|
Progression-free and overall survival
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jonathan Shamash, MD, FRCP, St. Bartholomew's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens, Non-Steroidal
- Estrogens
- Aspirin
- Dexamethasone
- Fosfestrol
- Diethylstilbestrol
Other Study ID Numbers
- BARTS-DAVDAS
- CDR0000472404 (Registry Identifier: PDQ (Physician Data Query))
- EU-20610
- ISRCTN13255144
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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