NCT01409200

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-26
• Primary completion: 2026-02-05
• Completion: 2026-02-05
• First posted: 2011-08-04
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study