This phase II trial studies how well rapid cycle combination therapy works in treating patients with prostate cancer that has not responded to surgery or hormone therapy and has spread to other places in the body. Androgen can cause the growth of tumor cells. Antihormone therapy, such as abiraterone acetate and enzalutamide, may lessen the amount of androgen made by the body. Drugs used in the chemotherapy, such as radium Ra 223 dichloride, cabazitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Switching between different combinations of androgen deprivation therapy and chemotherapy after a short time may prevent drug resistance and help achieve better long-term control of prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT02903160.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate time to disease progression, as determined by either prostate specific antigen (PSA) or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with metastatic castration-resistant prostate cancer (mCRPC).
SECONDARY OBJECTIVES:
I. To evaluate overall survival.
II. To assess PSA response rate with each treatment module.
III. To assess changes to alkaline phosphatase levels.
IV. To assess safety of the rapidly-cycling, non-cross reactive regimen.
EXPLORATORY OBJECTIVES:
I. To evaluate the correlation of a peripheral whole-blood ribonucleic acid (RNA) signature with clinical outcome measures during and after treatment.
II. To evaluate changes to AR-V7 expression in circulating tumor cells (CTCs) with different treatment modalities and clinical outcomes.
OUTLINE:
MODULE I: Patients receive abiraterone acetate orally (PO) once daily (QD). Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
MODULE II: Patients receive cabazitaxel IV on day 1 and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
MODULE III: Patients receive enzalutamide PO QD. Patients with known bone metastases also receive radium Ra 223 dichloride IV on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 1 year.
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorBobby Liaw
