Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-01 @ 5:28 PM
Study NCT ID:
NCT01385059
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2011-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Randomized, Phase II Study Assessing Axitinib as Pre-Surgical Therapy in Patients With High Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This randomized phase II trial studies how well axitinib works in treating patients with high-risk prostate cancer before undergoing surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if axitinib modulates pre-metastatic niche density in patients with high-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To determine if pre-metastatic niche density in regional lymph nodes (LNs) is associated with progression-free survival (PFS).
II. To determine if therapy with axitinib prolongs time to biochemical recurrence.
III. To determine if phosphorylated form of signal transducer and activator of transcription (pSTAT)3 in tumor tissue is associated with biochemical recurrence.
IV. To determine if myeloid derived suppressor cell (MDSC) recruitment in tumor tissue is associated with biochemical recurrence.
V. To determine if lysyl oxidase (LOX) expression in tumor tissue is associated with biochemical recurrence.
VI. To evaluate time to metastatic recurrence.
VII. To determine the rate of erectile dysfunction and urinary incontinence (grade \>= 3 for both) in the setting of preoperative axitinib therapy.
VIII. To evaluate changes in blood-based biomarkers (pSTAT3 and selected angiogenic factors) from baseline to the time of prostatectomy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer.
After completion of study treatment, patients are followed up periodically.
I. To determine if axitinib modulates pre-metastatic niche density in patients with high-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To determine if pre-metastatic niche density in regional lymph nodes (LNs) is associated with progression-free survival (PFS).
II. To determine if therapy with axitinib prolongs time to biochemical recurrence.
III. To determine if phosphorylated form of signal transducer and activator of transcription (pSTAT)3 in tumor tissue is associated with biochemical recurrence.
IV. To determine if myeloid derived suppressor cell (MDSC) recruitment in tumor tissue is associated with biochemical recurrence.
V. To determine if lysyl oxidase (LOX) expression in tumor tissue is associated with biochemical recurrence.
VI. To evaluate time to metastatic recurrence.
VII. To determine the rate of erectile dysfunction and urinary incontinence (grade \>= 3 for both) in the setting of preoperative axitinib therapy.
VIII. To evaluate changes in blood-based biomarkers (pSTAT3 and selected angiogenic factors) from baseline to the time of prostatectomy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28. Patients then undergo prostatectomy and pelvic lymph node dissection. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo prostatectomy and pelvic lymph node dissection at 5-6 weeks after biopsy confirmation of prostate cancer.
After completion of study treatment, patients are followed up periodically.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01105 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |