Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
研究概览
简要总结
This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVE:
I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.
SECONDARY OBJECTIVES:
I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.
II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).
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
- •Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
- •Patients with bone scan scheduled or performed
- •Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
- •Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
- •Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
- •Patients or their legal representatives must have the ability to read, understand and provide written informed consent
排除标准
- •Initiation of a new therapy between the PSMA PET/CT and the bone scans
- •Inability to provide written informed consent
- •Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
结局指标
主要结局
Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
时间窗: Up to 4 years
68Ga-PSMA-11 PET will be compared to bone scan/CT for M1b disease in prostate cancer patients progressing during androgen deprivation therapy. Patients who have at least one positive bone lesion will be rated positive. Patients will be treated as binary categorization. The analysis of the primary objective will utilize the McNemar's test to compare the detection rate between the imaging techniques.
次要结局
- Per-patient positive predictive value (PPV)(Up to 4 years)
- Number of lesions found by PSMA PET and bone scan + CT(Up to 4 years)
- Rate of M1 detection(Up to 4 years)
- Incidence of adverse events(Up to 4 years)
- PSA progression-free survival (PFS)(Up to 4 years)
- Overall survival (OS)(Up to 4 years)