ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Quality of Life - FACT-P
研究概览
简要总结
This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality of life between screening and month 12 of the study.
SECONDARY OBJECTIVES:
I. To assess prostate specific androgen (PSA) response rates across the entire population and compared between groups.
II. To assess impact of abiraterone and docetaxel on additional quality of life measurements and quality of life trends throughout the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically diagnosed adenocarcinoma of the prostate.
- •Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT, prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).
- •Eastern Cooperative Oncology Group (ECOG) performance status =<
- •Absolute neutrophil count (ANC) >= 1.5 k/uL.
- •Platelets >= 100 k/uL.
- •Hemoglobin >= 9 g/dL.
- •Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN.
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 4 x ULN for subjects with liver metastases.
- •Creatinine < 1.5 x ULN OR
- •Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 x ULN by Cockcroft-Gault formula or standard institutional practice.
- •Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- •Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as defined by the treating physician.
排除标准
- •No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy (example: bicalutamide) is allowed.
- •Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).
- •Patients have a histologic diagnosis of small cell prostate cancer or pure squamous cell prostate cancer.
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
- •The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- •Cardiovascular disorders:
- •Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.
- •Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
- •Stroke (including transient ischemic attack (TIA)), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic event within 3 months before first dose.
- •Other clinically significant disorders that would preclude safe study participation. As defined by the treating physician.
- •Known history of testing positive for human immunodeficiency virus (HIV) and cluster of differentiation 4 (CD4) count is below 200 or known acquired immunodeficiency syndrome diagnosis.
- •Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive) and a detectable viral count at screening.
- •Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use while on trial for the duration of potential docetaxel treatment. Live vaccine use is acceptable after chemotherapy or for patients randomized to the abiraterone arm. There are no restrictions on inactive viruses.
- •Known prior severe hypersensitivity to investigational product or any component in its formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).
研究组 & 干预措施
Arm A (ADT, docetaxel)
Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: Antiandrogen Therapy (Drug)
Arm A (ADT, docetaxel)
Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: Docetaxel (Drug)
Arm A (ADT, docetaxel)
Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm A (ADT, docetaxel)
Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm B (ADT, abiraterone acetate, prednisone)
Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Abiraterone Acetate (Drug)
Arm B (ADT, abiraterone acetate, prednisone)
Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Antiandrogen Therapy (Drug)
Arm B (ADT, abiraterone acetate, prednisone)
Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Prednisone (Drug)
Arm B (ADT, abiraterone acetate, prednisone)
Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm B (ADT, abiraterone acetate, prednisone)
Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Quality of Life - FACT-P
时间窗: Planned for up to one year, but actual was 3 months
The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.
次要结局
- Prostate Specific Antigen Progression Free Survival (PSA-PFS)(Planned up to 18 months, but actual was 3 months)
- Prostate-specific Antigen (PSA) Response(Planned for up to 18 months, but actual was 3 months)
- Change in Quality of Life - PROMIS Fatigue(Planned for up to 18 months, but actual was 3 months)
- Change in Quality of Life - FACT/GOG-NTX(Planned for up to 18 months, but actual was 3 months)