Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00316927
- Lead Sponsor
- St. Bartholomew's Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prostate-specific antigen (PSA) response
- Secondary Outcome Measures
Name Time Method Overall response Quality of life Progression-free and overall survival
Trial Locations
- Locations (15)
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Chelsea Westminster Hospital
🇬🇧London, England, United Kingdom
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Burnley General Hospital
🇬🇧Burnley, England, United Kingdom
Whipps Cross Hospital
🇬🇧London, England, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, 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