Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Proportion of Participants with New Lesions (Flare)
研究概览
简要总结
The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy.
The names of the treatment interventions involved in this study are:
- Androgen receptor antagonist monotherapy.
- PSMA PET/CT scan
It is expected that about 15 people will take part in this research study.
Participation in this research study is expected to last about 4 weeks.
详细描述
This research study is a pilot study, and it is the first time investigators are directly examining the effect of standard androgen receptor antagonists on Prostate-Specific Membrane Antigen (PSMA) expression for participants with recurrent, asymptomatic, metastatic hormone-sensitive prostate cancer (mHSPC). This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy.
The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, and follow up visits.
The names of the treatment interventions involved in this study are:
- Androgen receptor antagonist monotherapy.
- PSMA PET/CT scan
The U.S. Food and Drug Administration (FDA) has approved apalutamide, darolutamide, and enzalutamide for the treatment of prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients age 40 or higher with prostate cancer that has been previously treated with primary definitive local therapies (prostatectomy with or without salvage radiation, or primary prostate radiation) and subsequently experiencing rising PSA meeting criteria for biochemical failure (PSA >0.2 ng/dL x2 following prostatectomy, or PSA > 2 + nadir value following primary radiation).
- •PSMA PET/CT (Ga68, piflutolastat F-18, or other FDA-approved tracer) during time of biochemical recurrence, and within 6 weeks of registration, showing at least one lesion suspicious for recurrent prostate cancer based on size and/or SUV.
- •Testosterone >100 ng/dL within 6 months prior to enrollment with no intervening hormonal therapies.
- •Assigned by treating physician to receive standard-of-care AR antagonist monotherapy, using FDA-approved apalutamide, darolutamide, or enzalutamide.
排除标准
- •High disease burden, significant symptoms of disease, or other clinical situation requiring medical/surgical castration and/or docetaxel during the time of the study.
- •Not suitable for AR antagonist therapy (e.g. inability to swallow pills, poor adherence, advanced liver disease, prohibitive co-payment without available patient assistance funding, contraindicated drug-drug interaction).
- •Older-generation AR antagonists (e.g. bicalutamide) are not allowed on study.
研究组 & 干预措施
Androgen Receptor Antagonist Monotherapy
- Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care.
- Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.
干预措施: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi] (Drug)
Androgen Receptor Antagonist Monotherapy
- Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care.
- Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.
干预措施: Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan (Diagnostic Test)
结局指标
主要结局
Proportion of Participants with New Lesions (Flare)
时间窗: week 4
Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.
Proportion of Participants with New Lesions (Flare)
时间窗: week 1
Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.
次要结局
- Changes in serum PSA(week 4)
- Changes in tumor size(week 4)
- Changes in tumor SUV(week 4)
- Changes in tumor size(week 1)
- Changes in tumor SUV(week 1)
- Changes in serum PSA(week 1)
研究者
David J. Einstein
Principal Investigator
Beth Israel Deaconess Medical Center