Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer

Stage IV Prostate Cancer Clinical Trial

Official title: A Randomized, Phase II Study Assessing Axitinib as Pre-Surgical Therapy in Patients With High Risk Prostate Cancer

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

• NCT number: NCT01385059
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2011
• Completion date: October 9, 2013