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

ISRCTN	ISRCTN14557194
DOI	https://doi.org/10.1186/ISRCTN14557194
Secondary identifying numbers	PR03

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A prospective study to compare immediate with deferred treatment in advanced, localised and asymptomatic metastatic newly diagnosed prostatic carcinoma
Study hypothesis	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
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
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/08/2000
Overall study end date	01/08/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	Not provided at time of registration.
Total final enrolment	938
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 exclusion criteria	Not provided at time of registration.
Recruitment start date	01/08/2000
Recruitment end date	01/08/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/1997	15/11/2019	Yes	No

15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.