Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Change in Prostate Specific Antigen (PSA) Levels
研究概览
简要总结
Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.
详细描述
PRIMARY OBJECTIVE:
I. To determine the effects of low dose apalutamide on circulating levels of prostate specific antigen (PSA).
SECONDARY OBJECTIVES:
I. To determine the effect of low dose apalutamide on:
Ia. Reversibility of testosterone levels 7-14 days post intervention; Ib. Post-intervention plasma trough apalutamide concentration; Ic. Health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 confirmed organ-confined adenocarcinoma of the prostate (PCa) suitable for prostatectomy
- •Gleason score =< (4+4), however no Gleason pattern 5
- •Current serum PSA =< 20 ng/ml
- •Age > 18 years
- •Karnofsky >= 70%
- •Leukocytes >= 3,000/uL
- •Absolute neutrophil count >= 1,500/uL
- •Platelets >= 100,000/uL
- •Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 2.5 x institutional ULN
- •Creatinine < 2 x institutional ULN
- •Thyroid stimulating hormone (TSH) within the institutional normal range
- •Willing to use adequate contraception (barrier method; abstinence; subject has had a vasectomy; or partner is using effective birth control or is postmenopausal) for the duration of study participation
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Prior or ongoing hormonal treatment for prostate cancer including, but not limited to orchiectomy, antiandrogens, abiraterone, ketoconazole, or estrogens, or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists. Men on stable doses of 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) are eligible as long as there is no planned dose change while on study
- •Patients who have prostate cancer with distant metastases
- •Presence of neuroendocrine differentiation in the prostate biopsies
- •Serum testosterone (blood collected between 7-10 AM for men < 45 years of age and prior to 2 PM for men >= 45 years of age) < 200 ng/dL
- •Have a history of prior malignancies other than prostate cancer within the past 2 years, excluding non-melanoma skin cancer
- •Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration
- •History of seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- •Use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
- •Concurrent use of drugs in category X drug interactions with apalutamide
- •Participants may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical composition of apalutamide
- •Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Such illnesses/conditions may include, but are not limited to, hypertension, ongoing or active infection, or psychiatric illness/social situations
研究组 & 干预措施
Treatment (apalutamide)
Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (apalutamide)
Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.
干预措施: Quality-of-Life Assessment (Other)
Treatment (apalutamide)
Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.
干预措施: Apalutamide (Drug)
结局指标
主要结局
Change in Prostate Specific Antigen (PSA) Levels
时间窗: Baseline to end-of-intervention (mean 4.8 weeks; up to 9 weeks)
The proportion of participants with \>= 25% decline in PSA levels (from baseline to end-of-intervention) will be reported along with the 97.5% credible interval for the response rate based on the posterior distribution of the response rate derived from a non-informative prior for the response rate, which is consistent with the Bayesian approach.
次要结局
- Health-related Quality of Life (HRQOL)(Baseline to end of intervention (mean 4.8 weeks; up to 9 weeks))
- Health-related Quality of Life (HRQOL)(Baseline to end of intervention (mean 4.8 weeks; up to 9 weeks))
- Reversibility of Testosterone Levels(End-of-intervention to post-operation (mean 2.7 days; up to 7 days))
- Post-intervention Plasma Trough Apalutamide Concentrations(End-of-intervention (mean 4.8 weeks; up to 9 weeks))