A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Incidence of grade 3 or higher adverse events
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. Tolerability.
SECONDARY OBJECTIVES:
I. Tolerability in prespecified subpopulations.
II. Prostate-specific antigen (PSA) response at 7 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Abiraterone (Drug)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Prednisone (Drug)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Darolutamide (Drug)
结局指标
主要结局
Incidence of grade 3 or higher adverse events
时间窗: 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).
次要结局
未报告次要终点
研究者
Mamta Parikh
Principal Investigator
University of California, Davis