Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCTO46
Study information
Scientific title
A pilot study to assess flutamide monotherapy compared With maximal androgen blockade in metastatic prostate cancer
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. 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 names
Flutamide, goserelin acetate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1994
Overall trial end date
30/09/1996
Reason abandoned
Eligibility
Participant 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
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
01/01/1994
Recruitment end date
30/09/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Industry
Funder name
Schering-Plough Ltd (UK)
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