CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
axitinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01385059
NCT01385059Phase 2Completed
CompareCT.gov

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

City of Hope Medical Center·interventional·Posted Jun 29, 2011·Updated Mar 7, 2023

In Brief

A Phase 2 clinical trial evaluating axitinib, therapeutic conventional surgery, and 2 other interventions for Stage III Prostate Cancer and Stage IV Prostate Cancer. Completed, enrolled 11 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage III Prostate Cancer, Stage IV Prostate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2011
Enrollment StartOct 28, 2011
Primary CompletionOct 9, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.0 years ago

Interventions

axitinibdrug

Given PO

therapeutic conventional surgeryprocedure

Undergo prostatectomy and pelvic lymph node dissection

enzyme-linked immunosorbent assayother

Correlative studies

laboratory biomarker analysisother

Correlative studies