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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA 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 acronymIntercontinental Trial
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedProstate cancer
Intervention1. Intermittent androgen suppression
2. Continuous androgen deprivation
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment31/12/2005

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.