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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Prostate-specific antigen (PSA) response
Safety Issue:
No
Principal Investigator
Jonathan Shamash, MD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
St. Bartholomew's Hospital
Authority:
United States: Federal Government
Study ID:
BARTS-DAVDAS
NCT ID:
NCT00316927
Start Date:
December 2002
Completion Date:
April 2007
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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