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Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

NCT01409200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-03-03

No results posted yet for this study

Summary

This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.

Conditions

  • Metastatic Malignant Neoplasm in Lymph Node
  • Prostate Ductal Adenocarcinoma
  • Stage III Prostate Adenocarcinoma AJCC v7
  • Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

DRUG

Antiandrogen Therapy

Given per standard of care

DRUG

Axitinib

Given PO

PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

PROCEDURE

Regional Lymph Node Dissection

Undergo pelvic lymph node dissection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amado J Zurita Saavedra · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-26
Primary Completion
2026-02-05
Completion
2026-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409200 on ClinicalTrials.gov