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
- Compare the prostate-specific antigen (PSA) response in patients with locally advanced
or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs
- 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
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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Prostate-specific antigen (PSA) response
Jonathan Shamash, MD, FRCP
St. Bartholomew's Hospital
United States: Federal Government