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 (NCT) | NCT00316927 |
| Protocol serial number | N0205108850 |
| Sponsor | Department of Health (UK) |
| Funders | Barts and The London NHS Trust (UK), Orchid Cancer Appeal (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Jonathan Shamash
Scientific
Scientific
Medical Oncology Department
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
| Phone | +44 (0)20 7601 7313 |
|---|---|
| e.walsh@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Dexamethasone, aspirin, ranitidine, diethylstilboestrol |
| Primary outcome measure(s) |
1. PSA response rate |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 260 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Medical Oncology Department
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/02/2011 | Yes | No | |
| Plain English results | No | Yes |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
