Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
研究概览
简要总结
This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).
SECONDARY OBJECTIVES:
I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics.
II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation [PROMISE] criteria) under ARSI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate cancer
- •Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
- •Castration resistant disease with confirmed testosterone level =< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
- •New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
- •Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
- •Stated willingness to comply with continuation of ARSI treatment for the duration of the study
- •Provision of signed and dated informed consent form
排除标准
- •Inability to provide written informed consent
- •Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
- •Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
- •A baseline superscan pattern on bone scan
- •Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
研究组 & 干预措施
Diagnostic (68GA-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
干预措施: Computed Tomography (Procedure)
Diagnostic (68GA-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
干预措施: Gallium Ga 68 Gozetotide (Drug)
Diagnostic (68GA-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
时间窗: Baseline, assessed up to 1 year
Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
次要结局
- Prostate specific antigen (PSA) kinetics under ARSI(Baseline, assessed up to 1 year)
- Biochemical progression free survival (bPFS)(Up to 1 year)
- Changes in lesion size on cross sectional imaging under ARSI(Up to 1 year)
- Changes in staging (PSMA miTNM PROMISE criteria) under ARSI(Up to 1 year)
- Incidence of adverse events(Up to 1 year)