Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid | Drug | Aspirin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| diethylstilbestrol | Drug | Diethylstilbestrol | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prostate-specific antigen (PSA) response
Secondary outcomes (3)
- measure
- Overall response
- measure
- Quality of life
- measure
- Progression-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTShamash 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. PMID 21285990