A double-blind placebo controlled randomised trial of oral sodium clodronate for locally advanced prostatic adenocarcinoma

ISRCTN	ISRCTN61384873
DOI	https://doi.org/10.1186/ISRCTN61384873
Protocol serial number	PR04
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Mr Matthew Sydes
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Phone	+44 (0)207 6704700
Email	matthew.sydes@ctu.mrc.ac.uk

Primary study design	Interventional
Study design	Double-blind placebo controlled randomised trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To measure the efficacy and safety of clodronate in preventing symptomatic bone metastases
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	1. One group receives five years of oral sodium clodronate 2. The other group receives matching placebo for five years
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oral sodium clodronate
Primary outcome measure(s)	1. Time to symptomatic bone metastases 2. Overall survival
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/1997

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	500
Key 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/06/1994
Date of final enrolment	01/11/1997

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/05/2007		Yes	No
Results article	results	01/09/2009		Yes	No