Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0080056792
Study information
Scientific title
Acronym
Study hypothesis
This study will investigate patient acceptance, quality of life and survival/disease progression free interval in patients with locally advanced or metastatic prostate cancer in remission after six months treatment and disease control with androgen blockade.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer: Prostate
Intervention
Intermittent vs continuous sex hormone suppression
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Patient acceptance, quality of life and survival/disease progression.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/12/1997
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
200 patients recruited from Urological Oncology Clinical who have had six months androgen blockade.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/12/1997
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Urologist
London
E11 1NR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Orchid Cancer Appeal (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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15331894
Publication citations
-
Results
Lane TM, Ansell W, Farrugia D, Wilson P, Williams G, Chinegwundoh F, Philp T, Hines J, Oliver RT, Long-term outcomes in patients with prostate cancer managed with intermittent androgen suppression., Urol. Int., 2004, 73, 2, 117-122, doi: 10.1159/000079690.