Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
18/01/2016
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

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

Sponsor information

Organisation

Schering-Plough Ltd (UK)

Sponsor details

Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

18/01/2016: no publications found on PubMed.