This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.
Ability to understand and willingness to sign an informed consent form
Histologically confirmed prostate adenocarcinoma
Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
Have been on either abiraterone or darolutamide for > 28 days prior to initiating enrollment
Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial
Parallel
Abiraterone
DrugGiven abiraterone
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Darolutamide
DrugGiven darolutamide
Prednisone
DrugGiven prednisone
Incidence of grade 3 or higher adverse events
Will be defined and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
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University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
