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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06173362
Other study ID # UCDCC315
Secondary ID NCI-2023-09814UC
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 9, 2023
Est. completion date May 2027

Study information

Verified date December 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

PRIMARY OBJECTIVE: I. Tolerability. SECONDARY OBJECTIVES: I. Tolerability in prespecified subpopulations. II. Prostate-specific antigen (PSA) response at 7 months. OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference. ARM I: 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. ARM II: 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. After completion of study intervention, patients are followed up for a total of 3 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date May 2027
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 - Performance status 0 - 2 (Karnofsky = 50%) - Age = 18 years at time of consent - Life expectancy = 6 months per investigator discretion - Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abiraterone
Given abiraterone
Procedure:
Biospecimen Collection
Undergo collection of blood samples
Drug:
Darolutamide
Given darolutamide
Prednisone
Given prednisone

Locations

Country Name City State
United States University of California Davis Comprehensive Cancer Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Mamta Parikh National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). At 12 months
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