Study on Olaparib Maintenance After Cabazitaxel and Carboplatin in Men with Aggressive Prostate Cancer

Program Overview

The purpose of this study is to find out if olaparib, when used after cabazitaxel, carboplatin, and prednisone, can help manage aggressive variant prostate cancer (AVPC). While cabazitaxel, carboplatin, and prednisone are approved for certain prostate cancers, and olaparib is approved for some ovarian cancers, using them together in this way is experimental. Up to 96 men will participate in this study at MD Anderson.

Description

Study Groups:

If you qualify for this study, you will be randomly placed into one of two groups, like a roll of dice. This is because it's not known which group might be better. You have a 2 in 3 chance of being in Group 1 and a 1 in 3 chance of being in Group 2:

• Group 1: You will receive olaparib.
• Group 2: You will not receive olaparib.

All participants will receive cabazitaxel and carboplatin.

You and the study team will know which group you are in.

Study Drug Administration:

Each treatment cycle lasts 21 days.

• You will receive cabazitaxel through an IV for 60 minutes on Day 1 of Cycles 1-6.
• You will receive carboplatin through an IV for 60 minutes on Day 1 of Cycles 1-6.
• You will take prednisone tablets by mouth twice daily during Cycles 1-6.

You will also receive standard medications to help reduce side effects, which your doctor will explain.

• If you are in Group 1, you will start taking olaparib tablets twice daily by mouth from Day 1 of Cycle 7. Swallow the tablets whole and take them at the same time each day, at least 1 hour after and 2 hours before eating.
• If you are in Group 2, you will receive standard care after Cycle 6.

Length of Treatment:

You will receive cabazitaxel and carboplatin for up to 6 cycles. If you are in Group 1, you may continue olaparib as long as it benefits you. You may stop taking the study drugs if the cancer worsens, side effects are too severe, or you cannot follow the study directions.

Study Visits:

On Day 1 of Cycles 1-6:

• Physical exam
• Blood tests (up to 5 tablespoons) for routine checks and cancer markers
• Urine tests for cancer markers
• Bone scan and MRI or CT scan at Cycle 4

After Cycle 6, a second tumor biopsy will be done to compare with the initial one.

On Day 1 of Cycle 7:

• Blood tests for testosterone and cancer markers
• EKG
• Bone scan and MRI or CT scan

On Day 1 of Cycles 8-10:

• Physical exam
• Blood tests for routine checks and cancer markers
• Urine tests for cancer markers

After Cycle 10, visits will be every 3 cycles (Cycles 13, 16, 19, etc.):

• Physical exam
• Blood tests for routine checks and cancer markers
• Urine tests for cancer markers
• Bone scan and MRI or CT scan
• EKG

If you experience severe side effects, you may need more frequent visits.

End of Study Visit:

• Physical exam
• Bone scan and MRI or CT scan
• EKG
• Blood tests for routine checks and cancer markers
• Urine tests for cancer markers

Follow-Up:

Every 6 months after the study ends, your health will be checked by phone or chart review. Calls will last about 5 minutes and will stop if you leave the study.

Eligibility Criteria