Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
29/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Robert Shearer

ORCID ID

Contact details

Department of Urology
The Royal Marsden
Fullham Road
London
SW3 6JJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR06

Study information

Scientific title

Acronym

Study hypothesis

To determine whether total prostatectomy or radiotherapy confer benefit in terms of survival or development of metastases over no immediate treatment alone.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Prostate cancer

Intervention

1. The first group receives total prostatectomy
2. The second receive radiotherapy
3. The third receive no immediate treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Survival time to metastases
2. Morbidity
3. Local recurrence
4. Quality of life
5. Time to progression

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1994

Overall trial end date

01/06/1996

Reason abandoned

The overall target for recruitment was 1800 patients, but the trial accrued only 35 (mean age 69 years, median PSA level at entry 12 ng/mL). Recruitment was formally halted following the recommendation of the independent Data Monitoring Committee in October 1996.

Eligibility

Participant inclusion criteria

1. Newly diagnosed, biopsy-proven adenocarcinoma of the prostate
2. Stage T1b/T1c/T2, N0, M0
3. Negative bone scan
4. No previous malignancy (except skin)

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

1800 planned, 35 recruited at time of early closure in 1996.

Participant exclusion criteria

Opposite of inclusion criteria

Recruitment start date

01/06/1994

Recruitment end date

01/06/1996

Locations

Countries of recruitment

Belgium, Switzerland, United Kingdom

Trial participating centre

Department of Urology
London
SW3 6JJ
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 (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

Early closure in 1996 reported in 2004 in http://www.ncbi.nlm.nih.gov/pubmed/15610132

Publication citations

  1. Early closure of a randomized controlled trial of three treatment approaches to early localised prostate cancer: the MRC PR06 trial., BJU Int., 2004, 94, 9, 1400-1401, doi: 10.1111/j.1464-410X.2004.05224_3.x.

Additional files

Editorial Notes