Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031889
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2002-03-08
Brief Title:
Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 Androgens can stimulate the growth of prostate cancer cells Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery
PURPOSE Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery
Detailed Description:
OBJECTIVES
Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression luteinizing hormone-releasing hormone agonist or orchiectomy in patients with stage IV prostate cancer
Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients
Compare the quality of life QOL in patients treated with these regimens
Correlate prostate-specific antigen response and data of QOL including scores for pain intensity and analgesic consumption in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1-2 pain none or mild vs moderate or severe and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane once daily
Arm II Patients receive exemestane as in arm I and oral bicalutamide once daily
Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life and pain are assessed at baseline on day 1 of course 2 and any subsequent courses and at disease progression or treatment failure if applicable
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 20-62 patients 10-31 per treatment arm will be accrued for this study
Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression luteinizing hormone-releasing hormone agonist or orchiectomy in patients with stage IV prostate cancer
Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients
Compare the quality of life QOL in patients treated with these regimens
Correlate prostate-specific antigen response and data of QOL including scores for pain intensity and analgesic consumption in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1-2 pain none or mild vs moderate or severe and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane once daily
Arm II Patients receive exemestane as in arm I and oral bicalutamide once daily
Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life and pain are assessed at baseline on day 1 of course 2 and any subsequent courses and at disease progression or treatment failure if applicable
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 20-62 patients 10-31 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-20139 | None | None | None |