|
ISRCTN
|
ISRCTN61384873
|
|
DOI
|
10.1186/ISRCTN61384873
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
A double-blind placebo controlled randomised trial of oral sodium clodronate for locally advanced prostatic adenocarcinoma
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
PR04
|
|
Study hypothesis
|
To measure the efficacy and safety of clodronate in preventing symptomatic bone metastases
|
|
Lay summary
|
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=59
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Double-blind placebo controlled randomised trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Prostate cancer
|
|
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
|
Does not match inclusion criteria
|
|
Anticipated start date
|
01/06/1994
|
|
Anticipated end date
|
01/11/1997
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
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
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17505072
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19674936
|
|
Contact name
|
Mr
Matthew
Sydes
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 6704700
|
|
Email
|
matthew.sydes@ctu.mrc.ac.uk
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
12/04/2012
|
|
Date ISRCTN assigned
|
06/04/2000
|
