Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002855
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase 3 Trial of Androgen Ablation Alone vs ChemoHormonal Therapy as Initial Treatment of UnresectableMetastatic Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2018-10
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells It is not yet known which treatment regimen is more effective for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically
Detailed Description:
OBJECTIVES
Determine the clinical benefit as measured by time to progression and overall survival of chemohormonal therapy compared to androgen ablation alone when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy
Validate the clinical significance of PSA criteria for progression
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide bicalutamide or nilutamide
Arm II Patients receive chemohormonal therapy for 3 eight week courses followed by total androgen blockade Each course consists of 6 weeks of cytotoxic therapy with doxorubicin ketoconazole vinblastine and estramustine followed by 2 weeks of rest These patients are also maintained on hydrocortisone both during treatment and during rest
Patients in arm II have a long-term central venous access device inserted
PROJECTED ACCRUAL A total of 368 patients will be accrued for this study
Determine the clinical benefit as measured by time to progression and overall survival of chemohormonal therapy compared to androgen ablation alone when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy
Validate the clinical significance of PSA criteria for progression
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide bicalutamide or nilutamide
Arm II Patients receive chemohormonal therapy for 3 eight week courses followed by total androgen blockade Each course consists of 6 weeks of cytotoxic therapy with doxorubicin ketoconazole vinblastine and estramustine followed by 2 weeks of rest These patients are also maintained on hydrocortisone both during treatment and during rest
Patients in arm II have a long-term central venous access device inserted
PROJECTED ACCRUAL A total of 368 patients 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 |
|---|---|---|---|
| CDR0000065105 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-95231 | OTHER | None | None |
| NCI-G96-1044 | None | None | None |