Prostate cancer Cancer Malignant neoplam of prostate
Conditions
Interventions
1. One group receives five years of oral sodium clodronate
2. The other group receives matching placebo for five years
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Does not match inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to symptomatic bone metastases 2. Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed