Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 937
- 试验地点
- 1
- 主要终点
- Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
研究概览
简要总结
This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.
OUTLINE:
Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
After completion of study, patients are followed up within 3-12 months.
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
- •Patients who fulfill criteria for initial staging or restaging as outlined below:
- •Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
- •External radiation therapy (RT)
- •Other focal therapies
- •Systemic medical treatment
- •Watchful waiting
- •Assessment for subsequent treatment strategy (restaging), any of the following:
- •Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
- •Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
- •Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
- •Patients with known prostate cancer who undergo restaging because of new symptoms
- •Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
- •Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
- •Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
- •Capability to provide written informed consent
- •Able to remain still for duration of each imaging procedure (about 30 minutes)
排除标准
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- •Inability to provide written informed consent
研究组 & 干预措施
Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
干预措施: Computed Tomography (Procedure)
Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
时间窗: Up to 3-6 months after completion of imaging
A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.
次要结局
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)(From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months)
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS(From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months)
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival(From inclusion to date of death, assessed up to 12 months)
- Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location(Up to 12 months)