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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06173362
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone — DRUG
    Given abiraterone
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Darolutamide — DRUG
    Given darolutamide
  • Prednisone — DRUG
    Given prednisone

Study Details

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.

Key Dates

Start date
Nov 9, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (abiraterone, prednisone)
    Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.
  • Experimental: Arm II (darolutamide)
    Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

Primary Outcome Measure

Incidence of grade 3 or higher adverse events [ Time Frame: At 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Office of Clinical Research
[email protected]
916-382-6970
Mamta Parikh (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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