Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

Phase 3

• Conditions: Prostate Cancer

• Registration Number: NCT00003734
• Lead Sponsor: St. Luke's Hospital, Ireland

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.

Detailed Description

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-12-08
• Study First Posted: 2003-12-09
• Status Verified: 2011-12
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 276

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

Cork University Hospital; 🇮🇪 Cork, Ireland

Letterkenny Hospital; 🇮🇪 Donnegal, Ireland

St. Vincent's Hospital; 🇮🇪 Dublin, Ireland

Sligo General; 🇮🇪 Sligo, Ireland

Saint Luke's Hospital; 🇮🇪 Dublin, Ireland

Regional Hospital - Limerick; 🇮🇪 Limerick, Ireland

Mater Misericordiae Hospital; 🇮🇪 Dublin, Ireland

Adelaide and Meath Hospital; 🇮🇪 Dublin, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Bon Secours Hospital; 🇮🇪 Galway, Ireland

Belfast City Hospital Trust Incorporating Belvoir Park Hospital; 🇬🇧 Belfast, Northern Ireland, United Kingdom