Condition category
Cancer
Date applied
31/05/2001
Date assigned
31/05/2001
Last edited
09/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ncic.cancer.ca

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

Publication citations

Additional files

Editorial Notes

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.