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
ISRCTN | ISRCTN22761545 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN22761545 |
Secondary identifying numbers | NCIC PR7 |
- Submission date
- 31/05/2001
- Registration date
- 31/05/2001
- Last edited
- 18/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- 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
Contact information
Ms Sejal Patel
Scientific
Scientific
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
Phone | +44 (0)20 8722 4062 |
---|---|
Sejal.Patel@icr.ac.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Study acronym | Intercontinental Trial |
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. Intermittent androgen suppression 2. Continuous androgen deprivation |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2002 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Male |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/2002 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Canada
- England
- United Kingdom
Study participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Individual Sponsor (UK)
Research organisation
Research organisation
Prof David Dearnaley
The Royal Marsden NHS Trust
London
SM2 5NG
United Kingdom
Website | http://www.ncic.cancer.ca |
---|
Funders
Funder type
Government
NCRN UK funding + external funding
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Plain English results | No | Yes |
Editorial Notes
18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.