NCT01832259

A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection

A Neoadjuvant, Randomized, Phase II Study of Vascular Endothelial Growth Factor (VEGF) Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The area around a tumor ("pre-metastatic niche") may be an area to which cancer cells are attracted. The study doctor will take blood and tumor samples to look for certain features linked with response to treatment so that they can predict which future patients may benefit from this therapy. The purpose of this study is to see if the drug pazopanib can be used to reduce the amount of pre-metastatic niche in the patient's lymph nodes (a common site for prostate cancer to spread). Down the line, this may help to prevent prostate cancer from coming back after surgery.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Pazopanib	Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
OTHER	Placebo	Placebo tablet orally, daily for 28 days prior to radical prostatectomy.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-02-07
• Completion: 2018-08-09
• First posted: 2013-04-16
• Last updated: 2018-12-12
• Results posted: 2018-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study