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Neo-adjuvant Abiraterone + LHRH Versus LHRH in Prostate Cancer

2014-08-27 03:15:10 | BioPortfolio

Summary

The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone.

Primary Objective:

- To assess the difference in pathologic stage

- To characterize the effect of abiraterone acetate 1000 mg on the pharmacokinetics of a single dose of desipramine.

- To characterize the effect of abiraterone acetate 1000 mg on the pharmacokinetics of a single dose of theophylline.

Secondary Objective:

- To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B.

- To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B.

- To assess the difference in rate of positive surgical margins between Group A and Group B.

- To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.

Description

The Study Drugs:

Abiraterone acetate is designed to decrease the production of testosterone (male sex hormones), which plays a role in causing prostate cancer to grow.

Prednisone is commonly given in combination with other drugs to patients with prostate cancer. In this study, it is also being used in combination with abiraterone acetate in order to help prevent side effects that abiraterone acetate may cause.

LHRH Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone in the body. Prostate cancer cells need testosterone to survive.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. Within 14 days before you can begin taking the study drug(s), the following screening tests and procedures will be performed:

- Your complete medical history will be recorded and you will be asked about any drugs or treatments you may be receiving, including over-the-counter drugs, herbal remedies, vitamins, and/or supplements.

- You will be asked about any disease-related symptoms you may be experiencing.

- You will have a physical exam, including measurement of your height, weight, and vital signs (temperature, blood pressure, heart rate, and breathing rate).

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- You will have a digital rectal exam to check the status of the disease.

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your cholesterol, blood sugar, prostate-specific antigen (PSA), and testosterone levels. You will need to fast (not eat or drink anything except water) for at least 8 hours before this blood draw. If you are a diabetic, the study staff may provide special instructions about this requirement.

- Your cheek will be swabbed to collect cells for genetic testing. Urine will be collected for routine tests.

- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

- You will have a computed tomography (CT) scan or a magnetic resonance imaging (MRI) scan of your chest, abdomen, and pelvis to check the status of the disease. If you have had a chest x-ray recently, you may not need the chest CT.

- You will have a bone scan to check the status of the disease.

- You will have an echocardiogram or a multiple gated acquisition (MUGA) scan to check your heart function.

- You will have a bone marrow aspirate and biopsy to check the status of the disease. To collect a bone marrow aspirate/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Groups

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

- If you are in Group A, you will take abiraterone acetate, a LHRH analogue, and prednisone.

- If you are in Group B, you will receive a LHRH analogue alone.

You will have a 2 out of 3 chance of being placed in Group A. You have a 1 out of 3 chance of being placed in Group B.

Study Drug Administration:

Participants in Group A will take 4 pills of abiraterone acetate by mouth each day. You will take all 4 pills at the same time in the morning, either 1 hour before or 2 hours after a meal.

You will take prednisone by mouth once daily. It can, but does not have to be, taken at the same time as abiraterone acetate.

If you miss taking your abiraterone on any given day, please skip this dose, and return to your daily dose the next day. If you miss taking your prednisone dose on any given day, please skip this dose and return to your daily dose the next day.

Every 28-days is considered a "cycle." You should return all unused study drug and/or empty pill bottles at the end of each cycle.

You will receive an LHRH analogue (either leuprolide or goserelin). Leuprolide is given through a needle into your muscle, and goserelin is given through a needle under the skin in the abdomen. You will either receive 1 of these injections every 3 months or 1 injection each month, your doctor will describe the schedule to you. Which hormonal drug you are given (leuprolide or goserelin) will be assigned by your doctor and/or will depend on your insurance coverage.

Patients in Group B will only receive a LHRH analogue.

After 12 weeks of treatment in either group, you will have a prostatectomy (prostate surgery). For those in Group A, you should take abiraterone acetate and prednisone up to and including the day prior to surgery. Please let your surgeon know about your prednisone use. You will be separately consented for this surgery.

Study Visits:

Group A:

On Day 1 of each cycle, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- Blood (about 1-2 tablespoons) will be drawn for routine tests, to check your liver function, your PSA, and your blood sugar.

- Urine will be collected for routine testing.

On Day 15 of Cycle 1, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- Blood (about 1-2 tablespoons) will be drawn for routine tests, to check your liver function, and your blood sugar.

- You will also need to bring your study drug bottle with you so that the study staff can do a pill count.

On Day 15 of Cycles 2 and 3, blood (about 1 teaspoon) will be drawn to test your liver function.

About 1-3 days before your surgery, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your cholesterol, blood sugar, PSA, and testosterone levels. You will need to fast for at least 8 hours before this blood draw.

- Urine will be collected for routine tests.

- You will have a chest x-ray or a CT scan of your chest.

During treatment on this study, if your doctor thinks it is needed, you will have bone marrow aspiration/biopsy procedures to check the status of your disease.

Group B:

On Day 1 of each Cycle, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- Blood (about 3-4 teaspoons) will be drawn for routine tests, PSA level, blood sugar, and your liver function.

- Urine will be collected for routine tests.

About 1-3 days before your surgery, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs or treatments you may be receiving (including over-the-counter drugs, herbal remedies, vitamins, and/or supplements).

- Blood (about 3-4 teaspoons) will be drawn for routine tests and to check your cholesterol, blood sugar, PSA, and testosterone levels. You will need to fast for at least 8 hours before this blood draw.

- Urine will be collected for routine tests.

- You will have a chest x-ray or a CT scan of your chest.

Length of Study:

You will receive treatment on this study for about 3 months before having surgery to remove your prostate. You will be removed from this study if the disease gets worse, if you experience intolerable side effects, or your study doctor feels that it is in your best interest to stop the study. The study sponsor (Cougar Biotechnology) may decide to stop the study at any time.

Long-Term Follow-Up:

- You will return to the clinic 1 month after your surgery. At this visit, the following tests a procedures will be performed:

- Blood (about 1 teaspoon) will be drawn to measure your PSA level.

- You will complete a quality-of-life survey. The survey will take about 10 minutes to complete.

About 3 months, 6 months, and then every 6 months (for up to 8 years) after your surgery, the following tests and procedures will be performed:

- You will have a digital rectal exam to check the status of the disease.

- Blood (about 1 teaspoon) will be drawn to measure your PSA level. If your PSA becomes detectable, you will begin having yearly bone scans. If it increased to a certain level, a biopsy of the area where your prostate gland was may be required.

- Urine will be collected for routine tests (not at 3 months).

- You will complete the quality-of-life survey.

If your doctor thinks it is necessary, you will have a bone marrow biopsy and aspirate.

This is an investigational study. Prednisone is FDA approved and commercially available as a corticosteroid. Abiraterone acetate is not FDA approved or commercially available. At this time, it is only being used in research. Leuprolide acetate is FDA approved for metastatic or widespread prostate cancer. Using leuprolide for localized prostate cancer before surgery is investigational.

Up to 66 patients will be take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

Abiraterone Acetate, Prednisone, LHRHa

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:10-0400

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An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

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