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

Phase 3

Completed

• Conditions: Prostate cancer; Cancer; Prostate

• Registration Number: ISRCTN22761545
• Lead Sponsor: Individual Sponsor (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-05-31
• Study Completion: 2005-12-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 0

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

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified