Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

Prostate Cancer Clinical Trial

Official title: An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.

You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.

Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.

Study Visits:

You will have a study visit before each dose of radium-223. The following tests and procedures will be performed:

• You will have a physical exam.

• Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.

• Urine will be collected for biomarker testing.

At Week 12, you will have bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.

At Week 24 the following tests and procedures will be performed:

• You will have a physical exam.

• Blood (about 3-4 tablespoons) will be drawn for routine tests, as well as to check your PSA and testosterone levels.

Length of Study:

You may receive the study drug for up to 6 doses. You will be taken off study early if the disease gets worse, if you have intolerable side effects, if your study doctor thinks it is in your best interest to stop, or if you are unable to follow study directions.

End of Treatment Visit:

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

• You will have a physical exam.

• You will have a sodium fluoride PET/CT scan to check the status of the disease.

• Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.

• Urine will be collected for biomarker testing.

• You will have a bone marrow aspiration and biopsy performed for biomarker testing.

Long-Term Follow-Up:

The study staff will check up on you about every 6 months after your last dose of study drug. This will consist of a phone call, an e-mail, or a review of your medical records. If you are contacted by phone, the call will last about 5 minutes.

This is an investigational study. Radium-223 is FDA approved and commercially available for the treatment of metastatic CRPC that has spread to the bones but not to other organs. It is investigational to look for biomarkers that may be related to CRPC in patients who are receiving radium-223.

The study doctor can explain how the study drug is designed to work.

Up to 25 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02135484
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: N/A
• Start date: September 19, 2014
• Completion date: November 11, 2020