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

NCT01409200 | Completed Phase 2 FDA Drug

• 3 other identifiers: 2011-0231NCI-2015-01711NCI-2011-02749
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Participants Progression-free 12 months after surgery

  Time to Prostate-specific antigen (PSA)-progression measured from the date of radical prostatectomy to the occurrence of a serum PSA \>1.0 ng/mL (confirmed by a second measurement at least 2 weeks apart). PSA-monitoring every 3 months after surgery for the first 12 months, every 4 months in the second year, every 6 months in the third to fifth year, and yearly thereafter until PSA or radiologic progression.

  12 months after surgery

Study Arms (2)

Arm I (antiandrogen therapy, axitinib, surgery)

EXPERIMENTAL

Patients receive antiandrogen therapy per standard care and axitinib PO BID for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

Drug: Antiandrogen Therapy; Drug: Axitinib; Procedure: Radical Prostatectomy; Procedure: Regional Lymph Node Dissection

Arm II (antiandrogen therapy, surgery)

ACTIVE COMPARATOR

Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

Drug: Antiandrogen Therapy; Procedure: Radical Prostatectomy; Procedure: Regional Lymph Node Dissection

Interventions

Antiandrogen Therapy DRUG

Given per standard of care

Also known as: ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Arm I (antiandrogen therapy, axitinib, surgery); Arm II (antiandrogen therapy, surgery)

Axitinib DRUG

Given PO

Also known as: AG-013736, AG013736, Inlyta

Arm I (antiandrogen therapy, axitinib, surgery)

Radical Prostatectomy PROCEDURE

Undergo radical prostatectomy

Also known as: Prostatovesiculectomy

Arm I (antiandrogen therapy, axitinib, surgery); Arm II (antiandrogen therapy, surgery)

Regional Lymph Node Dissection PROCEDURE

Undergo pelvic lymph node dissection

Arm I (antiandrogen therapy, axitinib, surgery); Arm II (antiandrogen therapy, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with adenocarcinoma of the prostate that in the opinion of the urologist could be resected after response to systemic therapy; ductal adenocarcinoma is permitted
• Patients must be regarded as acceptable surgical risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
• All patients must have thorough tumor staging and meet at least one of the following criteria:
• Either lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer
• Non-bulky (\< 5 cm) regional pelvic or distant lymphadenopathy visualized on computed tomography (CT)/magnetic resonance imaging (MRI) scan; lymph node biopsy is required if \< 2.0 cm or in atypical distribution
• Primary tumor Gleason score \>= 8 and serum prostate-specific antigen (PSA) concentration \>= 25 ng/mL, indicating high risk of occult lymph node metastases
• Primary clinical tumor stage of T3 and Gleason score \>= 7, indicating high risk of occult lymph node metastases
• Primary tumor stage T4, indicating high risk of occult lymph node metastases; patients in any of these groups and less than 3 sites of non-predominantly lytic bone metastasis will be still considered eligible for the trial; the 2010 American Joint Committee on Cancer (AJCC) staging system will be followed
• Prior hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist with or without antiandrogen) up to 8 weeks is permitted
• Absolute peripheral neutrophil count (ANC) of \>= 1,500/mm\^3
• Platelet count of \>= 100,000/mm\^3
• Total bilirubin of =\< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
• Serum creatinine =\< 1.5 x ULN or clearance \>= 60 mL/min (measured or calculated)

You may not qualify if:

• Patients with biopsy-proven small cell or sarcomatoid histology
• Patients with clinical or radiological evidence of bone (\>= 3 sites, or predominantly lytic if \< 3) or other extranodal metastasis
• Patients who have had prior chemotherapy, experimental agents for prostate cancer, or patients receiving more than 8 weeks of prior hormone therapy will be excluded
• Gastrointestinal abnormalities such as inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection; treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes
• Anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine); grapefruit juice is also a CYP3A4 inhibitor
• Anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e. carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort)
• Patients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapy
• Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, cerebrovascular accident or transient ischemic attack in the 12 months prior to randomization; or deep vein thrombosis or pulmonary embolism in the 6 months prior to randomization
• Persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease, or human immunodeficiency virus (HIV) infection
• Inadequately controlled hypertension (defined as systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg) despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Anticipation of need for major surgical procedure during the course of the study other than as outlined by the protocol
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization
• Serious, non-healing wound, active ulcer, or untreated bone fracture; any bone fractures must be healed
• Known hypersensitivity to any component of axitinib or prior use of axitinib

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphatic Metastasis

Interventions

Androgen Antagonists; Axitinib

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amado J Zurita Saavedra

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: March 26, 2012
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)