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

Phase 2

Recruiting

• Conditions: Advanced Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8
• Interventions: Drug: Abiraterone; Procedure: Biospecimen Collection; Drug: Darolutamide; Drug: Prednisone

• Registration Number: NCT06173362
• Lead Sponsor: Mamta Parikh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-11
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (abiraterone, prednisone)	Biospecimen Collection	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 (darolutamide)	Biospecimen Collection	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.
Arm II (darolutamide)	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.
Arm I (abiraterone, prednisone)	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.
Arm I (abiraterone, prednisone)	Abiraterone	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.

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3 or higher adverse events	At 12 months	Will be defined and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).

Trial Locations

Locations (1)

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States