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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.

Clinical Trial Description

Study Drug Administration:

If participant is found to be eligible to take part in this study, participant will receive daratumumab 1 time each week for 4 weeks before participant's prostatectomy. During Week 1, participant's dose of daratumumab will be given over 8 hours. After that, each dose will be given over about 4 hours.

Length of Study:

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

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

Study Visits:

During Weeks 1-4:

- Participant will have a physical exam

- Blood (about 2 tablespoons) will be drawn for routine and blood type testing.

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

During Week 6 (the week of participant's surgery):

- Participant will have a physical exam

- Blood (about 2 tablespoons) will be drawn for routine tests, including measurements of participant's PSA and testosterone levels. Part of this sample will also be used for 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 participant's blood type will be performed before participant receives daratumumab. Participant should carry the blood type card with participant while participant is on this study.

- Participant will have surgery to remove participant's prostate. Participant 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 participant's PSA and testosterone levels.

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

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.

Study Design

Related Conditions & MeSH terms

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