Contact information
Type
Scientific
Primary contact
Ms Sejal Patel
ORCID ID
Contact details
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 (0)20 8722 4062
Sejal.Patel@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCIC PR7
Study information
Scientific title
A phase III randomised trial comparing intermittent versus continuous androgen suppression for patients with prostate-specific-antigen (PSA) progression in the clinical absence of distant metastases following radiotherapy for prostate cancer
Acronym
Intercontinental Trial
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Prostate cancer
Intervention
1. Intermittent androgen suppression
2. Continuous androgen deprivation
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the prostate prior to initiation of radiotherapy
2. Previous pelvic radiotherapy for prostate cancer
3. Serum PSA >3 ng/ml and higher than the lowest level recorded previously since the end of radiotherapy and must be done within 1 month prior to randomisation
4. Serum testosterone greater than or equal to 7 mmol/L and must be done within 1 month prior to randomisation
5. No definite evidence of metastatic disease
6. Chest X-ray performed within 8 weeks prior to randomisation and is negative for metastases
7. No radiotherapy in the 12 months preceding randomisation
8. No prior hormonal therapy (except neoadjuvant cytoreduction prior to radiotherapy or prostatectomy for a maximum duration of 8 months)
9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
10. Aged at least 16 years
11. Life expectancy >5 years
12. Able to complete QOL questionnaires
13. Within 28 days prior to randomisation: Bilirubin - NO greater than 1.5 x upper normal limit (UNL) aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) - NO greater than 1.5 x UNL alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) - NO greater than 1.5 x UNL lactic dehydrogenase (LDH) - NO greater than 1.5 x UNL Creatinine - NO greater than 1.5 x UNL
14. Adequate birth control for duration of study
15. Informed consent
16. Accessible for follow-up
17. Luteinising hormone-releasing hormone (LHRH) analogue and antiandrogen must begin within 5 working days of randomisation
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Canada, United Kingdom
Trial participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
Sponsor information
Organisation
Individual Sponsor (UK)
Sponsor details
Prof David Dearnaley
The Royal Marsden NHS Trust
London
SM2 5NG
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
NCRN UK funding + external funding
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