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NCT number NCT03177460
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Sumit K. Subudhi, MD, PHD
Phone 713-563-1602
Status Recruiting
Phase Phase 1
Start date June 7, 2017
Completion date June 2019

Clinical Trial Summary

The goal of this clinical research study is to learn about the safety and tolerability of giving Darzalex (daratumumab) to patients who have prostate cancer before having an already-scheduled prostatectomy (surgical removal of the prostate).

Researchers also want to learn if daratumumab can help to control the disease before the prostatectomy.

This is an investigational study. Daratumumab is FDA approved and commercially available to treat multiple myeloma. It is considered investigational to use daratumumab in patients with prostate cancer.

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

Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive daratumumab by vein 1 time each week for 4 weeks before your prostatectomy. During Week 1, your dose of daratumumab will be given over 8 hours. After that, each dose will be given over about 4 hours.

In this study, the following will be done to lower the chance of a daratumumab infusion related reaction:

- You will get medications, including steroids, acetaminophen, and/or antihistamine before the infusion. If you are considered high risk, you may also get medications, including inhaled steroids, after the infusion.

- The infusion may be slowed down or stopped if you have a reaction.

- You may stay overnight in the hospital after the infusion so the study staff can check your health.

You may ask the study staff for more information about the types of medications you will receive to lower your chance of an infusion-related reaction, including how they are administered and their risks.

Length of Study:

You may receive up to 4 doses of daratumumab. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the Week 18 visit (described below).

Study Visits:

During Weeks 1-4:

- You will have a physical exam

- Blood (about 2 tablespoons) will be drawn for routine and blood type testing. ┬░Daratumumab treatment will interfere with blood type testing which is needed before blood transfusions can be given. For this reason, a test to find out your blood type will be performed before you receive daratumumab. You should carry the blood type card with you while you are on this study.

- During Week 3 only, blood (about 1-2 teaspoons) will be drawn to check your PSA levels.

During Week 6 (the week of your surgery):

- You will have a physical exam

- Blood (about 2 tablespoons) will be drawn for routine tests, including measurements of your PSA and testosterone levels. Part of this sample will also be used for blood type testing.

- You will have surgery to remove your prostate. You will sign a separate consent form explaining the procedure and its risks in more detail.

End-of-Study Visit:

During Week 18, blood (about 2 tablespoons) will be drawn for routine tests, including measurements of your PSA and testosterone levels.

If you withdrew from the study before Week 18, the study staff may call you to ask how you are doing. This call should last about 5-10 minutes.

Study Design

Related Conditions & MeSH terms

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