| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN14557194 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | PR03 |
| Public title | A Prospective Study to Compare Immediate with Deferred Treatment in Advanced, Localised and Asymptomatic Metastatic Newly Diagnosed Prostatic Carcinoma |
| Scientific title |
|
| Acronym | N/A |
| 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 proven adenocarcinoma of the prostate
2. Stage T2-T4 M0 or T1-T4 M1 (provided metastases are asymptomatic)
3. World Health Organisation (WHO) performance status 0-2
4. Life expectancy of >1 year
5. No previous or coexisting non prostatic malignancy except basal cell carcinoma
6. No previous treatment for prostatic carcinoma other than transurethral resection (TUR)
7. Patients in whom a deferred policy is inappropriate should not be entered into this study |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/08/2000 |
| Anticipated end date | 01/08/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | 1. Immediate Group: Total or subcapsular orchidectomy or administration of a Lutenizing Hormone Releasing Hormone (LHRH) analogue. Suggested LHRH analogues are goserelin acetate (Zoladex) 3.6 mg monthly or leuprorelin (Prostap SR) 3.75 mg monthly. LHRH treatment to start within 6 weeks of randomisation.
2. Deferred Group: No hormone treatment until disease progression. The original protocol specified orchidectomy only as the method of androgen deprivation. The protocol was later modified to allow the use of LHRH analogues. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | UK Medical Research Council |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| 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 | ISRCTN14557194 |
| Date last extracted from ISRCTN register | 17/04/2008 |
