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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN61384873 |
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Date of registration:
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06/04/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A double-blind placebo controlled randomised trial of oral sodium clodronate for locally advanced prostatic adenocarcinoma
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Scientific title:
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Date of first enrolment:
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01/06/1994 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN61384873 |
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Study type:
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Interventional |
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Study design:
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Double-blind placebo controlled randomised trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Matthew
Sydes |
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Address:
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MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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+44 (0)207 6704700 |
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Email:
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matthew.sydes@ctu.mrc.ac.uk |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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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: Does not match inclusion criteria
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate cancer
Cancer
Malignant neoplam of prostate
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Intervention(s)
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1. One group receives five years of oral sodium clodronate
2. The other group receives matching placebo for five years
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Primary Outcome(s)
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1. Time to symptomatic bone metastases
2. Overall survival
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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