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A randomised phase II trial of dexamethasone and aspirin (DA) versus dexamethasone, diethylstilboestrol and aspirin (DAS) in locally advanced or metastatic cancer of the prostate

A randomised phase II trial of dexamethasone and aspirin (DA) versus dexamethasone, diethylstilboestrol and aspirin (DAS) in locally advanced or metastatic cancer of the prostate

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13255144
Enrollment
260
Registered
2003-09-12
Start date
2001-01-01
Completion date
Unknown
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Malignant neoplasm of the prostate

Interventions

Randomised phase II clinical trial, 130 in each arm: Group 1: receiving 'DA' which is a combination of dexamethasone, aspirin and ranitidine Group 2: receiving 'DAS' dexamethasone, aspirin, ranitidine

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: North East Thames region (Whipps Cross, Oldchurch, King George, St. Bartholomew's). Patients over the age of 18 years who have locally advanced metastatic prostate specific antigen (PSA)-positive adenocarcinoma after failure of gonadotropin releasing hormone (GnRH) analogue therapy, radiation therapy, surgery or any combination of these.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. PSA response rate 2. Quality of life

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026