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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00316927
First received: April 19, 2006
Last updated: May 12, 2011
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: acetylsalicylic acid
Drug: dexamethasone
Drug: diethylstilbestrol
 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316927

Locations
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
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Whipps Cross Hospital
London, England, United Kingdom, E11 1NR
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
Investigators
Study Chair: Jonathan Shamash, MD, FRCP St. Bartholomew's Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00316927     History of Changes
Other Study ID Numbers: CDR0000472404, BARTS-DAVDAS, EU-20610, ISRCTN13255144
Study First Received: April 19, 2006
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Aspirin
Dexamethasone acetate
Dexamethasone
BB 1101
Dexamethasone 21-phosphate
Fosfestrol
Diethylstilbestrol
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013