Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003734
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
1999-11-01
Brief Title:
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
St Lukes Hospital Ireland
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98060 | None | None | None |
| ICORG-97-01 | None | None | None |