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ISRCTN
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ISRCTN22761545
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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Intercontinental Trial
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Serial number at source
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NCIC PR7
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada, United Kingdom
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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1. Intermittent androgen suppression
2. Continuous androgen deprivation
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NCRN UK funding + external funding
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Trial website
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Publications
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Contact name
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Ms
Sejal
Patel
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Address
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Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
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City/town
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Sutton, Surrey
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Zip/Postcode
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SM2 5NG
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Country
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United Kingdom
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Tel
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+44 (0)20 8722 4062
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Fax
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+44 (0)20 8770 7876
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Email
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Sejal.Patel@icr.ac.uk
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Sponsor
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Individual Sponsor (UK)
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Address
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Prof David Dearnaley
The Royal Marsden NHS Trust
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City/town
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London
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Zip/Postcode
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SM2 5NG
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Country
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United Kingdom
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Sponsor website:
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http://www.ncic.cancer.ca
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Date applied
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31/05/2001
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Last edited
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05/08/2008
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Date ISRCTN assigned
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31/05/2001
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