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

June 25, 2013 updated by: St. Bartholomew's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Burnley, England, United Kingdom, BB10 2PQ
        • Burnley General Hospital
      • Canterbury, England, United Kingdom, CT2 3NG
        • Kent and Canterbury Hospital
      • Eastbourne, England, United Kingdom, BN21 2UD
        • Eastbourne District General Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, E11 1NR
        • Whipps Cross Hospital
      • London, England, United Kingdom, SW10 9NH
        • Chelsea Westminster Hospital
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Milton Keynes, England, United Kingdom, MK6 5LD
        • Milton Keynes General Hospital
      • Oxford, England, United Kingdom, OX3 7LJ
        • Churchill Hospital
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Torquay Devon, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Weston-super-Mare, England, United Kingdom, BS23 4TQ
        • Weston General Hospital
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prostate-specific antigen (PSA) response

Secondary Outcome Measures

Outcome Measure
Quality of life
Overall response
Progression-free and overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Bartholomew's Hospital

Investigators

  • Study Chair: Jonathan Shamash, MD, FRCP, St. Bartholomew's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 19, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BARTS-DAVDAS
  • CDR0000472404 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20610
  • ISRCTN13255144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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