Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00003734|
Recruitment Status : Unknown
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 9, 2003
Last Update Posted : July 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: flutamide Drug: triptorelin Radiation: radiation therapy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Official Title:||A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer|
|Study Start Date :||December 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003734
|Cork University Hospital|
|St. Vincent's Hospital|
|Dublin, Ireland, 4|
|Saint Luke's Hospital|
|Dublin, Ireland, 6|
|Mater Misericordiae Hospital|
|Dublin, Ireland, 7|
|Adelaide and Meath Hospital|
|Dublin, Ireland, 8|
|Dublin, Ireland, 9|
|Bon Secours Hospital|
|Galway University Hospital|
|Regional Hospital - Limerick|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Study Chair:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|