Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Jonathan Shamash

ORCID ID

Contact details

Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 7313
e.walsh@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00316927

Protocol/serial number

N0205108850

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Phase II

Drug names

Dexamethasone, aspirin, ranitidine, diethylstilboestrol

Primary outcome measures

1. PSA response rate
2. Quality of life

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2001

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

260

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

01/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Oncology Department
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Orchid Cancer Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21285990

Publication citations

  1. Results

    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, 104, 4, 620-628, doi: 10.1038/bjc.2011.7.

Additional files

Editorial Notes