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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22761545
Enrollment
Unknown
Registered
2001-05-31
Start date
2002-01-01
Completion date
Unknown
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate

Interventions

1. Intermittent androgen suppression 2. Continuous androgen deprivation

Sponsors

Individual Sponsor (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

Canada, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026