A pilot study to assess flutamide monotherapy compared With maximal androgen blockade in metastatic prostate cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study to assess flutamide monotherapy compared With maximal androgen blockade in metastatic prostate cancer
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	1. Group A: Oral flutamide 250 mg three times daily 2. Group B: Oral flutamide 250 mg three times daily plus either orchidectomy or the lutenizing hormone releasing hormone (LHRH) analogue Zoladex (goserelin acetate). Zoladex is given by monthly injection at the dosage recommended by the manufacturer
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Flutamide, goserelin acetate
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/1996

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Key inclusion criteria	1. Histologically confirmed prostate carcinoma 2. Skeletal metastases on bone scan, with radiological conformation if appropriate, or typical sclerotic metastases on X-ray 3. Life expectancy >6 months 4. Suitable for treatment by any of the study therapies 5. No previous hormonal therapy 6. Not currently receiving corticosteroids, spironolactone or aminoglutethamide 7. Adequate renal and hepatic function
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1994
Date of final enrolment	30/09/1996

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

29/10/2019: No publications found. All search options exhausted.
18/01/2016: no publications found on PubMed.