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)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: acetylsalicylic acid Drug: dexamethasone Drug: diethylstilbestrol Phase 3

Detailed Description:



  • 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
Allocation: Randomized
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Prostate-specific antigen (PSA) response

Secondary Outcome Measures :
  1. Overall response
  2. Quality of life
  3. Progression-free and overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316927

United Kingdom
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 Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom, MK6 5LD
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Torbay Hospital
Torquay Devon, England, United Kingdom, TQ2 7AA
Weston General Hospital
Weston-super-Mare, England, United Kingdom, BS23 4TQ
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Cancer Care Centre at York Hospital
York, England, United Kingdom, Y031 8HE
Sponsors and Collaborators
St. Bartholomew's Hospital
Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital

Publications of Results: Identifier: NCT00316927     History of Changes
Other Study ID Numbers: BARTS-DAVDAS
CDR0000472404 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic