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

NCT00316927 | Completed Phase 3

• 4 other identifiers: BARTS-DAVDASCDR0000472404EU-20610ISRCTN13255144
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 15

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Prostate-specific antigen (PSA) response

Secondary Outcomes (3)

• Overall response

• Quality of life

• Progression-free and overall survival

Interventions

acetylsalicylic acid DRUG

dexamethasone DRUG

diethylstilbestrol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Bartholomew's Hospital: lead

Study Sites (15)

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Burnley General Hospital

Burnley, England, BB10 2PQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 3NG, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, England, BN21 2UD, United Kingdom

Location

Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Chelsea Westminster Hospital

London, England, SW10 9NH, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Related 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 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Dexamethasone; Diethylstilbestrol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Stilbestrols; Stilbenes; Benzylidene Compounds

Study Officials

• Jonathan Shamash, MD, FRCP

  St. Bartholomew's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: December 1, 2002
• Study Completion: April 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-04

Locations

GB (15)