A Phase 2 interventional study of Cabazitaxel and Carboplatin in Prostate Cancer Aggressiveness and Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if olaparib, when given after treatment with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant prostate cancer (AVPC). The safety of these drugs will also be studied.
This is an investigational study. Cabazitaxel and carboplatin are FDA approved and commercially available for the treatment of certain types of prostate cancer. Prednisone is FDA-approved and commercially available as a corticosteroid. Olaparib is FDA approved and commercially available for the treatment of certain types of ovarian cancer. The combination of cabazitaxel and carboplatin followed by olaparib in this study is investigational.
The study doctor can describe how the study drugs are designed to work.
Up to 96 participants will be enrolled on this study. All will take part at MD Anderson.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have a 2 in 3 chance of being assigned to Group 1 and a 1 in 3 chance of being assigned to Group 2:
All participants will receive cabazitaxel and carboplatin.
You and the study staff will know to which group you have been assigned.
Study Drug Administration:
Each study cycle is 21 days.
You will receive cabazitaxel by vein over 60 minutes on Day 1 of Cycles 1-6. You will then receive carboplatin by vein over 60 minutes on Day 1 of Cycles 1-6.
You will take 1 tablet of prednisone by mouth 2 times each day of Cycles 1-6.
You will be given standard drugs to help decrease the risk of side effects (for example, filgrastim) before and/or after each dose of cabazitaxel and continuing through several days. Your doctor will describe these drugs to you in more detail, including how they are given and any side effects you may expect.
If you are in Group 1, you will take tablets of olaparib 2 times by mouth each day starting on Day 1 of Cycle 7. Swallow the whole tablet or tablets. Do not chew, crush, divide, or dissolve the tablets. If you vomit shortly after taking your olaparib tablet you can retake a new dose as long as you can see that the tablet came out whole. You should take the doses at the same time each day (or within 2 hours of the scheduled times). Do not take the dose if you forget and it is more than 2 hours since your scheduled time. Take olaparib at least 1 hour after and 2 hours before eating.
If you are in Group 2, you will receive standard of care treatment and follow-up after Cycle 6. The study doctor will tell you more about what this may mean for you.
Length of Treatment:
You will receive carboplatin and cabazitaxel for up to 6 cycles. If you are in Group 1, you may continue receiving olaparib for as long as the doctor thinks it is in your best interest. You may no longer be able to take the study drugs 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 follow-up visits.
Study Visits:
On Day 1 of Cycles 1-6:
After Cycle 6, you will have a second tumor biopsy for biomarker testing to compare to the one taken at screening. The type of biopsy you have will depend on where the disease has spread and/or what the doctor thinks is in your best interest. The doctor will discuss with you the type of biopsy you will have.
On Day 1 of Cycle 7:
On Day 1 of Cycles 8-10:
After Cycle 10, you will only have study visits every 3 cycles. Beginning on Day 1 of Cycle 13, every 3 cycles (Cycles 13, 16, 19, and so on):
If you have severe side effects, you may return to the clinic more often so the study doctor can check on your health.
End of Study Visit:
When you leave the study, the following tests and procedures will be performed:
Follow-Up:
About every 6 months after the end-of-study visit, the study staff will check your health. This will be done either by a chart review or a phone call. If you are called, this call will last about 5 minutes. These calls will stop if you withdraw from the study.
Exclusion Criteria:
Cabazitaxel, Cabazitaxel and Carboplatin intravenously on day 1 of cycles 1-6. Prednisone by mouth twice daily on days 1-21 of cycles 1-6.
Drug: Cabazitaxel · Drug: Carboplatin · Drug: Prednisone 5Mg
Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7.
Drug: Olaparib
Participants randomized to observation only beginning cycle 7.
25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.
Also known as: Jevtana
AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6
Also known as: Paraplatin
5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.
Administered by mouth twice daily at a dose of 300 mg by mouth twice daily, dispensed on Day 1 of cycle 7 to participants randomized to receive olaparib maintenance and every 21 days thereafter until the participant completes the study, withdraws from the study or the closure of the study.
Also known as: Olaparib Pill
Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation
Progression Free Survival (PFS) calculated as the time from randomization until any one of the following events occurs, whichever comes first: * Documented disease progression * Start of a new therapy in the absence of progression * Death in the absence of progression
Time frame: Up to one year from time of randomization
Genomic alterations in DNA damage repair (DDR) pathway genes induced and/or selected by carboplatin and cabazitaxel chemotherapy [biopsy #2 vs biopsy #1]: Association with clinical outcome (PFS>6 months)
Time frame: Up to one year
Rate of adverse events possibly, probably or definitely attributable to olaparib following cabazitaxel plus carboplatin in men with AVPC
Time frame: Up to one year
Overall survival (OS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance vs observation
Time frame: Up to one year
Response evaluation criteria in solid tumors (RECIST) and prostate specific antigen (PSA) response rate (RR) to cabazitaxel + carboplatin induction, and to olaparib maintenance in men with AVPC
Time frame: Up to one year
Association between DDR pathway gene expression changes following carboplatin + cabazitaxel chemotherapy and clinical outcome (PFS>6 months)
Time frame: Up to one year
Collection and archiving of serum, plasma, and urine samples in study patients for later hypothesis generating associations
Time frame: Up to one year
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Prostate Cancer, Hereditary, 7
M.D. Anderson Cancer Center