Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004124
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
1999-12-10
Brief Title:
S9921 Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
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 Hormones can stimulate the production of prostate cancer cells Hormone therapy may fight prostate cancer by reducing the production of androgens Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy mitoxantrone and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer
PURPOSE This randomized phase III trial is studying hormone therapy mitoxantrone and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer
Detailed Description:
OBJECTIVES
Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy
Compare the qualitative and quantitative toxic effects of these regimens in this patient population
Compare the prostate-specific antigen PSA progression-free survival rate in patient treated with these regimens
Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to surgical extent of disease organ confined vs not organ confined but N0 vs N1 Gleasons sum less than 7 vs 7 vs greater than 7 and planned radiotherapy yes vs no Patients are randomized to one of two treatment arms
Arm IPatients receive goserelin subcutaneously once every 13 weeks 8 injections total and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone
Patients may undergo radiotherapy 5 days a week for 65-78 weeks beginning anytime arm I or after completion of chemotherapy arm II at the discretion of the physician in the absence of disease progression or unacceptable toxicity
Patients are offered the possibility to participate in biomarker research by allowing their tissueblood to be studied
Patients are followed every 6 months for 2 years and then annually for up to 13 years
PROJECTED ACCRUAL A total of 1360 patients 680 per treatment arm will be accrued for this study within 95 years
Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy
Compare the qualitative and quantitative toxic effects of these regimens in this patient population
Compare the prostate-specific antigen PSA progression-free survival rate in patient treated with these regimens
Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to surgical extent of disease organ confined vs not organ confined but N0 vs N1 Gleasons sum less than 7 vs 7 vs greater than 7 and planned radiotherapy yes vs no Patients are randomized to one of two treatment arms
Arm IPatients receive goserelin subcutaneously once every 13 weeks 8 injections total and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity
Arm IIPatients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone
Patients may undergo radiotherapy 5 days a week for 65-78 weeks beginning anytime arm I or after completion of chemotherapy arm II at the discretion of the physician in the absence of disease progression or unacceptable toxicity
Patients are offered the possibility to participate in biomarker research by allowing their tissueblood to be studied
Patients are followed every 6 months for 2 years and then annually for up to 13 years
PROJECTED ACCRUAL A total of 1360 patients 680 per treatment arm will be accrued for this study within 95 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | CALGB | httpsreporternihgovquickSearchU10CA032102 |
| S9921 | OTHER | None | None |
| CALGB-99904 | OTHER | None | None |