Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316927
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

April 19, 2006
April 21, 2006
June 26, 2013
December 2002
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Prostate-specific antigen (PSA) response
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Complete list of historical versions of study NCT00316927 on Archive Site
  • Overall response
  • Quality of life
  • Progression-free and overall survival
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Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
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

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.



  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Drug: acetylsalicylic acid
  • Drug: dexamethasone
  • Drug: diethylstilbestrol
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2007
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  • 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


  • 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


  • 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
CDR0000472404 ( Registry Identifier: PDQ (Physician Data Query) )
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St. Bartholomew's Hospital
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Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital
National Cancer Institute (NCI)
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP