Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00316927|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: acetylsalicylic acid Drug: dexamethasone Drug: diethylstilbestrol||Phase 3|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Official Title:||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|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||April 2007|
- Prostate-specific antigen (PSA) response
- Overall response
- Quality of life
- Progression-free and overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316927
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Burnley General Hospital|
|Burnley, England, United Kingdom, BB10 2PQ|
|Kent and Canterbury Hospital|
|Canterbury, England, United Kingdom, CT2 3NG|
|Eastbourne District General Hospital|
|Eastbourne, England, United Kingdom, BN21 2UD|
|Whipps Cross Hospital|
|London, England, United Kingdom, E11 1NR|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Chelsea Westminster Hospital|
|London, England, United Kingdom, SW10 9NH|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Milton Keynes General Hospital|
|Milton Keynes, England, United Kingdom, MK6 5LD|
|Oxford, England, United Kingdom, OX3 7LJ|
|Romford, England, United Kingdom, RM7 OBE|
|Torquay Devon, England, United Kingdom, TQ2 7AA|
|Weston General Hospital|
|Weston-super-Mare, England, United Kingdom, BS23 4TQ|
|Worthing, England, United Kingdom, BN11 2DH|
|Cancer Care Centre at York Hospital|
|York, England, United Kingdom, Y031 8HE|
|Study Chair:||Jonathan Shamash, MD, FRCP||St. Bartholomew's Hospital|