Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Matthew Sydes

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)207 6704700
matthew.sydes@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR04

Study information

Scientific title

Acronym

Study hypothesis

To measure the efficacy and safety of clodronate in preventing symptomatic bone metastases

Ethics approval

Not provided at time of registration

Study design

Double-blind placebo controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Oral sodium clodronate

Primary outcome measures

1. Time to symptomatic bone metastases
2. Overall survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1994

Overall trial end date

01/11/1997

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

500

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/1994

Recruitment end date

01/11/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17505072
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19674936

Publication citations

  1. Results

    Mason MD, Sydes MR, Glaholm J, Langley RE, Huddart RA, Sokal M, Stott M, Robinson AC, James ND, Parmar MK, Dearnaley DP, , Oral sodium clodronate for nonmetastatic prostate cancer--results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873)., J. Natl. Cancer Inst., 2007, 99, 10, 765-776, doi: 10.1093/jnci/djk178.

  2. Results

    Dearnaley DP, Mason MD, Parmar MK, Sanders K, Sydes MR, Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials., Lancet Oncol., 2009, 10, 9, 872-876, doi: 10.1016/S1470-2045(09)70201-3.

Additional files

Editorial Notes