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

Amino Acids

Hormones

Docetaxel

Goserelin

Imatinib Mesylate

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Tyrosine

Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m\^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months

30 mg/m\^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.

Hormone injections given every other month or every 3 months, as determined by the doctor.

Goserelin Acetate

Paul Mathew, MD

Primary Objective:

1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.

Secondary Objectives:

1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer.
2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.

Docetaxel is a drug that was designed to help kill cancer cells. Imatinib mesylate is a drug designed to block cancer cells from growing and dividing. Hormonal treatment with Lupron (leuprolide) or Zoladex (goserelin acetate) is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive. All patients will have their prostate gland removed after treatment with these drugs.

Before treatment starts, you will be asked questions about your medical history and have a complete physical examination. You will have blood drawn (2 tablespoons) for routine blood tests. You will be asked questions about any medications you are currently taking and have taken in the past. You will have an electrocardiogram (ECG - a test that measures electrical activity of the heart). As part of your standard care for prostate cancer, you will also have a computed tomography (CT) scan (or magnetic resonance imaging ((MRI)) scan) of the abdomen and pelvis along with a bone scan (x-rays of the bones) to see if the prostate cancer has moved to other parts of your body.

For this study, you will receive hormone injections to lower the levels of testosterone in the blood. You will also take imatinib mesylate capsules by mouth and receive treatment with docetaxel by vein to help kill the cancer cells before surgery.

You will receive hormone therapy with either leuprolide or goserelin acetate injections, whichever your doctor feels will give you the most benefit. The hormone injections will be given every other month or every 3 months. During treatment with the hormones, you will also take an anti-androgen drug called Casodex (bicalutamide) by mouth for up to 2 weeks. This drug is being used to help decrease the risks of developing side effects due to the hormone injections (this is the standard of care with hormone treatments). You will take imatinib mesylate capsules every day for 6 weeks starting with the hormone treatments. You will also receive treatment with docetaxel. Docetaxel injections are given by vein over 60 minutes once a week for 4 weeks in a row. This will be followed by 2 weeks with no docetaxel. This 6 week period is considered a course of treatment. You will have up to 3 courses of treatment (18 weeks) with docetaxel. After this treatment is complete, you will have prostate surgery within 4 weeks or when you have fully recovered from treatment.

During treatment, your general health will be monitored and you will have physical exams and blood tests (about 1-2 tablespoons) often to make sure that you are tolerating the treatment safely. If the disease gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

Before surgery, you will be given a general anesthetic. An incision (cut) will be made in your abdomen (lower stomach area) and your prostate gland and lymph nodes in the pelvis will be removed. Before the procedure, the risks will be explained to you and you will need to sign a separate consent form.

After surgery, you will have check-up visits every 3 months for 1 year, then every 6 months for the rest of your life. At these visits, you will have a physical exam and around 1-2 tablespoons of blood collected for routine lab tests. If your doctor feels it is necessary, you may also have CT scans, bone scans, and/or x-rays. These tests are being done to check if the cancer has come back. If the cancer comes back, you will be removed from the study and your doctor will discuss treatment options with you.

This is an investigational study. The leuprolide or goserelin acetate injections, bicalutamide tablets, imatinib mesylate capsules, and docetaxel injections are all FDA approved and are commercially available. Up to 36 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer

Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer	NCT00500110	Prostate Cancer	Docetaxel Imatinib Mesyla... Leuprolide Goserelin Aceta...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hormonal ablation