Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies

Prostate Cancer Clinical Trial

Official title: Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies

Status Completed

Clinical Trial Summary

You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body.

This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational.

Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Clinical Trial Description

The Study Drugs:

Abiraterone acetate is designed to block male hormones in the body that may cause prostate cancer to grow.

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

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.

Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 4 tablets of abiraterone acetate by mouth every day. The tablets should be taken all at once, at least 1 hour before a meal or 2 hours after a meal. You will also take 1 tablet of prednisone by mouth 2 times each day. You will take both of these drugs throughout the entire study.

If the disease gets worse while you are taking abiraterone acetate and prednisone, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.

• If you are assigned to Group 1, you will start taking sunitinib malate. You will take 3 capsules by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone.

• If you are assigned to Group 2, you will start taking dasatinib. You will take 2 tablets by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone. Dasatinib tablets should be swallowed whole, with or without a meal. If you accidentally miss taking a dose of dasatinib, it may be taken within 12 hours later. If you vomit within 30 minutes of taking the tablets, that dose may be repeated. If you miss a dose due to side effects, the dose should not be replaced.

If the disease gets worse after you have been assigned to a group, and you are still eligible to continue taking the study drugs, you will "crossover" to the other group. If you were in Group 1, you would stop taking sunitinib malate and begin taking dasatinib. If you were in Group 2, you would stop taking dasatinib and begin taking sunitinib malate. No matter which group you crossover to, you will continue taking abiraterone acetate and prednisone.

Study Visits:

At each study visit, you will be asked about any other drugs you may be receiving and about any side effects you may be having.

Every 2 weeks during the first 12 weeks of taking abiraterone acetate and prednisone and during the first 3 cycles (9-12 weeks) of each new treatment combination, blood (about 1-2 tablespoons) will be collected to test your liver function.

Every 4 weeks, the following tests and procedures will be performed:

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

• Blood (about 1-2 tablespoons) and urine will be collected for routine tests. Part of this blood will be used to measure your PSA and your levels of a specific marker of prostate cancer.

• You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.

• You will be asked about any other drugs you may be taking.

• Your performance status will be recorded.

If the disease gets worse (or you change treatments) at any point in the study, the following tests and procedures will be performed:

• Blood (about 1-2 tablespoons) and urine will be collected for routine tests.

• You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.

• You will have an ECG and an echocardiogram or a MUGA scan.

• You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.

If your doctor thinks it is necessary:

°You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study if the disease gets worse after crossover, if you experience intolerable side effects, or if the doctor thinks that it is in your best interest.

End of Treatment Visit:

After you stop receiving the study drugs for any reason, the following tests and procedures will be performed:

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

• Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your PSA level, your level of a specific marker of prostate cancer, and to check for a protein related to cancer.

• You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.

• You will be asked about any other drugs you may be taking.

• Your performance status will be recorded.

• You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.

Post-Treatment (Safety) Follow-Up Visit:

About 30 days after your last dose of study drugs, the following tests and procedures will be performed:

• You will have a physical exam, including a measurement of your vital signs.

• Blood (about 1-2 teaspoons) will be drawn for routine tests.

• Your performance status will be recorded.

• You will be asked about any side effects you may have experienced since your last visit.

• You will be asked about any other drugs you may be taking.

Long-Term Follow-Up:

A member of the study staff will check up on you about every 6 months after your Post-Treatment (Safety) Follow-Up Visit. This will consist of a phone call, an e-mail, or a review of your medical and/or other records. If you are contacted by phone, the call will only last a few minutes.

After your End-of-Treatment visit, the study staff will contact you by phone, e-mail, or you will come in for a clinic visit. You will be asked about how you are feeling and any side effects you may have had. Each follow-up will take about 5 minutes. Follow-up will take place every 3 months for the first 2 years, every 6 months for the third year, and 1 time a year after that. The last follow-up will be about 5 years after the last patient is enrolled. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01254864
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2011
• Completion date: December 7, 2023