NCT01385059

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	axitinib	Given PO
PROCEDURE	therapeutic conventional surgery	Undergo prostatectomy and pelvic lymph node dissection
OTHER	enzyme-linked immunosorbent assay	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-10-28
• Primary completion: 2013-10-09
• Completion: 2013-10-09
• First posted: 2011-06-29
• Last updated: 2023-03-07
• Results posted: 2023-03-07

Locations

1 site across 1 country: United States