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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316927
• Other study ID #: BARTS-DAVDAS
• Secondary ID: CDR0000472404EU-
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2006
• Last updated: June 25, 2013
• Start date: December 2002
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• acetylsalicylic acid

• dexamethasone

• diethylstilbestrol

Locations

Country	Name	City	State
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Burnley General Hospital	Burnley	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Eastbourne District General Hospital	Eastbourne	England
United Kingdom	Chelsea Westminster Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Whipps Cross Hospital	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Churchill Hospital	Oxford	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Weston General Hospital	Weston-super-Mare	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
St. Bartholomew's Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 prostat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-specific antigen (PSA) response			No
Secondary	Overall response			No
Secondary	Quality of life			No
Secondary	Progression-free and overall survival			No