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

Stage IV Prostate Adenocarcinoma AJCC v7 Clinical Trial

Official title: Pre-Surgical Androgen Deprivation Therapy With or Without Axitinib in Previously Untreated Prostate Cancer Patients With Known or Suspected Lymph Node Metastasis

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To compare the proportion of patients progression-free one year after treatment with axitinib plus androgen deprivation versus (vs.) androgen deprivation therapy alone and surgery in newly diagnosed prostate cancer patients with lymph node metastases (TxN1M0 or TxNxM1a) or clinical suspicion of lymph node metastases. SECONDARY OBJECTIVES: I. To compare the rate of pathologic complete response (pCR) in the primary tumor. II. To evaluate time to progression. III. Describe the perioperative and postoperative morbidity of pre-surgical treatment. IV. Evaluate the effects of a 6-month time course of androgen deprivation with or without axitinib in prostate cancer tissue and blood. V. Develop a prospective tissue archive of prostate tumors that have metastasized to lymph nodes. OUTLINE: Patients receive antiandrogen therapy per standard care for 8 weeks. Patients are then randomized to 1 of 2 treatment arms. ARM I: Patients receive antiandrogen therapy per standard care and axitinib orally (PO) twice daily (BID) for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection. ARM II: Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection. After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then yearly thereafter. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Lymphatic Metastasis
• Metastatic Malignant Neoplasm in Lymph Node
• Neoplasms
• Prostate Ductal Adenocarcinoma
• Prostatic Neoplasms
• Stage III Prostate Adenocarcinoma AJCC v7
• Stage IV Prostate Adenocarcinoma AJCC v7

• NCT number: NCT01409200
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 26, 2012
• Completion date: June 30, 2025