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Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

NCT06173362 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Prostate Adenocarcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8

Interventions

DRUG

Abiraterone

Given abiraterone

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Darolutamide

Given darolutamide

DRUG

Prednisone

Given prednisone

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mamta Parikh · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2026-11-30
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173362 on ClinicalTrials.gov