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

ISRCTN	ISRCTN13255144
DOI	https://doi.org/10.1186/ISRCTN13255144
ClinicalTrials.gov number	NCT00316927
Secondary identifying numbers	N0205108850

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Dr Jonathan Shamash
Scientific

Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Phone	+44 (0)20 7601 7313
Email	e.walsh@qmul.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	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
Study hypothesis	1. To assess the response rate, survival and quality of life of patients with locally advanced or metastatic prostate cancer 2. To assess if deferred diethystilboestrol offers similar results with fewer side effects
Ethics approval(s)	Not provided at time of registration
Condition	Prostate cancer
Intervention	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 and diethylstilbestrol in combination
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Dexamethasone, aspirin, ranitidine, diethylstilboestrol
Primary outcome measure	1. PSA response rate 2. Quality of life
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2001
Overall study end date	01/01/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	260
Participant 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.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/01/2001
Recruitment end date	01/01/2005

Medical Oncology Department

London
EC1A 7BE
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Barts and The London NHS Trust (UK)

No information available

Orchid Cancer Appeal (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	15/02/2011		Yes	No

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)