| Source of record | UK Trials |
| ISRCTN | ISRCTN61384873 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | PR04 |
| Public title | A double-blind placebo controlled randomised trial of oral sodium clodronate for locally advanced prostatic adenocarcinoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer |
| Study hypothesis | To measure the efficacy and safety of clodronate in preventing symptomatic bone metastases |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological diagnosis of adenocarcinoma of the prostate
2. TNM categories T2-T4, N0-N3, NX, M0
3. No evidence of bone metastases on bone scan within 4 weeks of randomisation
4. No known nodal disease outside pelvis
5. Normocalcaemic (serum calcium within the normal range of the participating centre)
6. Patients may be treated with any standard management policy for localised disease (radiotherapy, surgery, androgen deprivation or observation) or have had such treatment in the past
7. WHO performance status of 0, 1 or 2
8. No concomitant or previous use of other bisphosphonates
9. Serum creatinine less than two times upper limit of normal range of the centre
10. No administration of any investigational drug within 12 months
11. Diagnosis of disease within last 3 years |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/06/1994 |
| Anticipated end date | 01/11/1997 |
| Status of trial | Completed |
| Target number of participants | 500 |
| Interventions | 1. One group receives five years of oral sodium clodronate
2. The other group receives matching placebo for five years |
| Primary outcome measure(s) | 1. Time to symptomatic bone metastases
2. Overall survival |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17505072 |
| Sources of funding | Medical Research Council (UK) |
| 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 | Mr Matthew Sydes |
| Contact details | -
-
United Kingdom
- |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61384873 |
| Date last extracted from ISRCTN register | 17/04/2008 |
