Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR03

Study information

Scientific title

A prospective study to compare immediate with deferred treatment in advanced, localised and asymptomatic metastatic newly diagnosed prostatic carcinoma

Acronym

Study hypothesis

Not provided at time of registration.

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate cancer

Intervention

1. Immediate Group: Total or subcapsular orchidectomy or administration of a Lutenizing Hormone Releasing Hormone (LHRH) analogue. Suggested LHRH analogues are goserelin acetate (Zoladex) 3.6 mg monthly or leuprorelin (Prostap SR) 3.75 mg monthly. LHRH treatment to start within 6 weeks of randomisation.

2. Deferred Group: No hormone treatment until disease progression. The original protocol specified orchidectomy only as the method of androgen deprivation. The protocol was later modified to allow the use of LHRH analogues.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/08/2000

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven adenocarcinoma of the prostate
2. Stage T2-T4 M0 or T1-T4 M1 (provided metastases are asymptomatic)
3. World Health Organisation (WHO) performance status 0-2
4. Life expectancy of >1 year
5. No previous or coexisting non prostatic malignancy except basal cell carcinoma
6. No previous treatment for prostatic carcinoma other than transurethral resection (TUR)
7. Patients in whom a deferred policy is inappropriate should not be entered into this study

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/08/2000

Recruitment end date

01/08/2005

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

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

Publication citations

Additional files

Editorial Notes