Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003645
Status:
TERMINATED
Last Update Posted:
2020-04-28
First Post:
1999-11-01
Brief Title:
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PI request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Testosterone can stimulate the growth of prostate cancer cells Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy
PURPOSE Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery
PURPOSE Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery
Detailed Description:
OBJECTIVES
Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression
Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival
Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels
Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition
Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year
Arm II Patients receive no initial treatment Quality of life is assessed every 6 months for 5 years Quality of life of wivespartners of patients is assessed every 6 months for two years
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 496 patients 248 per treatment arm will be accrued for this study within 35 years
Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression
Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival
Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels
Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition
Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year
Arm II Patients receive no initial treatment Quality of life is assessed every 6 months for 5 years Quality of life of wivespartners of patients is assessed every 6 months for two years
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 496 patients 248 per treatment arm will be accrued for this study within 35 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2009-00818 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-ID-97077 | OTHER | None | None |
| E-97077 | None | None | None |
| NCI-T97-0069 | None | None | None |
| CDR0000066733 | REGISTRY | None | None |