Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
1. One group receives 3 years of oral sodium clodronate
2. The other group receives a matching placebo for 3 years
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Proven histological diagnosis of prostate cancer or Prostate-Specific Antigen (PSA) more than 100 mg/l 2. Metastatic bone disease demonstrated on bone scan or skeletal radiographs (Stage M1b) 3. Patients commencing or clinically responding to initial hormone treatment with orchidectomy, Luteinising Hormone Releasing Hormone (LHRH) analogues, cyproterone acetate, flutamide or complete androgen blockade but with no previous hormone treatment 4. Normocalcaemic (serum calcium within the normal range of the centre) 5. WHO performance status of 0, 1 or 2 6. No concomitant or previous use of other bisphosphonates 7. Serum creatinine less than twice upper limit of normal range of centre 8. No administration of any investigational drug within 12 months
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to symptomatic bone progression; overall survival; impact on analgesic consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed