| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN92984394 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SCTO46 |
| Public title | A Pilot Study to Assess Flutamide Monotherapy Compared With Maximal Androgen Blockade in Metastatic Prostate Cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Prostate |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 30/09/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Schering-Plough Ltd |
| Sponsor name | Schering-Plough Ltd |
| Sponsor details | Schering-Plough House
Shire Park
Welwyn Garden City
United Kingdom
AL7 1TW |
| Sponsor telephone | +44(0)1707 363636 |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92984394 |
| Date last extracted from ISRCTN register | 17/04/2008 |
