A pilot study to assess flutamide monotherapy compared With maximal androgen blockade in metastatic prostate cancer
| ISRCTN | ISRCTN92984394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92984394 |
| Secondary identifying numbers | SCTO46 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 29/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot study to assess flutamide monotherapy compared With maximal androgen blockade in metastatic prostate cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | 1. Group A: Oral flutamide 250 mg three times daily 2. Group B: Oral flutamide 250 mg three times daily plus either orchidectomy or the lutenizing hormone releasing hormone (LHRH) analogue Zoladex (goserelin acetate). Zoladex is given by monthly injection at the dosage recommended by the manufacturer |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Flutamide, goserelin acetate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1994 |
| Completion date | 30/09/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Histologically confirmed prostate carcinoma 2. Skeletal metastases on bone scan, with radiological conformation if appropriate, or typical sclerotic metastases on X-ray 3. Life expectancy >6 months 4. Suitable for treatment by any of the study therapies 5. No previous hormonal therapy 6. Not currently receiving corticosteroids, spironolactone or aminoglutethamide 7. Adequate renal and hepatic function |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1994 |
| Date of final enrolment | 30/09/1996 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Schering-Plough Ltd (UK)
Industry
Industry
Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
"ROR" |
https://ror.org/00148fb49 |
|---|
Funders
Funder type
Industry
Schering-Plough Ltd (UK)
No information available
Results and Publications
| 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 |
Editorial Notes
29/10/2019: No publications found. All search options exhausted.
18/01/2016: no publications found on PubMed.
