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

PR05

Study information

Scientific title

Acronym

Study hypothesis

Measure the efficacy and safety of oral sodium clodronate in preventing symptomatic bone disease

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

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Prostate cancer

Intervention

1. One group receives 3 years of oral sodium clodronate
2. The other group receives a matching placebo for 3 years

Intervention type

Drug

Phase

Not Specified

Drug names

Oral sodium clodronate

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1994

Overall trial end date

01/07/1998

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

311

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/1994

Recruitment end date

01/07/1998

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 (0)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

Funder name

Boehringer Mannheim / Roche (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12953084
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19674936

Publication citations

  1. Results

    Dearnaley DP, Sydes MR, Mason MD, Stott M, Powell CS, Robinson AC, Thompson PM, Moffat LE, Naylor SL, Parmar MK, , A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial)., J. Natl. Cancer Inst., 2003, 95, 17, 1300-1311.

  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