Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
NCT ID: NCT00316927
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2002-12-31
2007-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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acetylsalicylic acid
dexamethasone
diethylstilbestrol
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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St. Bartholomew's Hospital
OTHER
Principal Investigators
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Jonathan Shamash, MD, FRCP
Role: STUDY_CHAIR
St. Bartholomew's Hospital
Locations
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Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Burnley General Hospital
Burnley, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Eastbourne District General Hospital
Eastbourne, England, United Kingdom
Whipps Cross Hospital
London, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Chelsea Westminster Hospital
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Weston General Hospital
Weston-super-Mare, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Countries
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References
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Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. doi: 10.1038/bjc.2011.7. Epub 2011 Feb 1.
Other Identifiers
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CDR0000472404
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20610
Identifier Type: -
Identifier Source: secondary_id
ISRCTN13255144
Identifier Type: -
Identifier Source: secondary_id
BARTS-DAVDAS
Identifier Type: -
Identifier Source: org_study_id
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