Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244920
Status:
WITHDRAWN
Last Update Posted:
2012-05-28
First Post:
2005-10-25
Brief Title:
Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
An Open Label Randomized Phase 2 Study To Evaluate The Activity Tolerability And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing Radical Prostatectomy
Status:
WITHDRAWN
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor withdrew drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Androgens can cause the growth of prostate cancer cells Drugs such as leuprolide and bicalutamide may stop the adrenal glands from making androgens Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer
PURPOSE This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer
Detailed Description:
OBJECTIVES
Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy
Compare the duration of clinical disease-free survival of patients treated with these regimens
Determine the applicability of prostate-specific antigen PSA serology as an endpoint determinant in patients treated with these regimens
Compare the feasibility and potential safety effects on wound healing and recovery in patients treated with these regimens before and after a radical prostatectomy
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive leuprolide intramuscularly once a month for 3 months and oral bicalutamide once a day for 2 weeks
Arm II Patients receive leuprolide and bicalutamide as in arm I plus squalamine lactate IV over 4 hours once weekly for 6 weeks
Seven weeks after beginning treatment patients in both arms undergo standard radical prostatectomy Patients then continue to receive leuprolide and bicalutamide with or without squalamine lactate for up to 6 additional weeks
After completion of study treatment patients are followed periodically for at least 3 years
PROJECTED ACCRUAL A total of 132 patients 66 per treatment arm will be accrued for this study
Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy
Compare the duration of clinical disease-free survival of patients treated with these regimens
Determine the applicability of prostate-specific antigen PSA serology as an endpoint determinant in patients treated with these regimens
Compare the feasibility and potential safety effects on wound healing and recovery in patients treated with these regimens before and after a radical prostatectomy
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive leuprolide intramuscularly once a month for 3 months and oral bicalutamide once a day for 2 weeks
Arm II Patients receive leuprolide and bicalutamide as in arm I plus squalamine lactate IV over 4 hours once weekly for 6 weeks
Seven weeks after beginning treatment patients in both arms undergo standard radical prostatectomy Patients then continue to receive leuprolide and bicalutamide with or without squalamine lactate for up to 6 additional weeks
After completion of study treatment patients are followed periodically for at least 3 years
PROJECTED ACCRUAL A total of 132 patients 66 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 |
|---|---|---|---|
| OHSU-IRB-357 | None | None | None |
| OHSU-MSI-1256F-204 | None | None | None |