Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Hormonal

Sunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist.

Intramuscular injection either monthly for 3 months or in a single 3-month dose.

LHRH Agonist

25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.

Sunitinib Malate

Radical prostatectomy after completion of Sunitinib and LHRH agonist.

Radical Prostatectomy

Amado Zurita, MD

The goal of this clinical research study is to learn if the addition of sunitinib malate (SU011248) to hormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed.

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Hormonal treatment is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and weight). Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a computerized tomography (CT) or magnetic resonance imaging (MRI) scan, a bone scan, or a chest x-ray to evaluate the status of your disease. You will be asked about any medications or treatments you are currently taking. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and an echocardiogram. An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. Your ability to perform daily activities will also be evaluated. You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

If you are found to be eligible to take part in this study, you will take the sunitinib malate by mouth 1 time a day for 30 days together with hormonal ablation therapy. You will receive hormone injections to lower the levels of testosterone in the blood. Hormonal therapy may be given either monthly for 3 months or in a single 3-month dose. Every 30 days is considered a study "cycle." You may receive up to 3 cycles of treatment.

On Day 1 of each cycle, you will have a physical exam and you will be asked about your medical history. Blood (about 2 teaspoons) will be drawn for routine tests. You will be asked about any medications you have taken and any side effects you may have experienced. You will be asked questions about your ability to perform daily activities (performance status evaluation.)

On Day 15 of Cycle 1, you will be asked about any side effects you have experienced. Blood (about 2 teaspoons) will be drawn for routine testing.

After completing 3 cycles of treatment, you will have surgery to remove your prostate. The surgery will occur 1-2 weeks after you receive the last dose of study drug.

After the last dose of the study drug, you will have a follow-up visit. You will be asked about any side effects you are experiencing and you will have a physical exam. You will also have digital rectal exam. Blood (about 2 teaspoons) will be drawn for routine tests. You will also have an echocardiogram. An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size.

You will have a follow-up visit, 28 days after you stop treatment. You will have a physical exam and your complete medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests. You will be asked about any medications you have taken and any side effects you may have experienced. You will have a performance status evaluation. You will have an echocardiogram if it was abnormal at your last visit.

About 3 months after your surgery, you will return for another follow-up visit. You will have a physical exam and your complete medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation.

For the first year after surgery you will have a prostate specific antigen (PSA) blood test every 3 months. Two (2) years after surgery you will begin having PSA tests every 6 months.

This is an investigational study. Sunitinib malate has been authorized by the FDA for research purposes only. About 64 patients will take part in this study. All will be enrolled at M. D. Anderson.

Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

A Phase II Neoadjuvant Trial of Sunitinib Malate (SU011248) Plus Hormonal Ablation for Patients Who Have High Risk Localized Prostate Cancer and Will Undergo Prostatectomy

Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.

Pfizer

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy	NCT00329043	Prostate Cancer	LHRH Agonist Sunitinib Malat... Radical Prostat...	-	M.D. Anderson Cancer Center
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy	NCT00329043	Prostate Cancer	LHRH Agonist Sunitinib Malat... Radical Prostat...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ductal adenocarcinoma of the prostate