A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN38477744
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 311

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

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to symptomatic bone progression; overall survival; impact on analgesic consumption.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration