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

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
Email	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

Sponsor information

Individual Sponsor (UK)
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.