NCT06655064终止不适用
Prospective Observational Multicenter Registry Study to Assess the Impact & Long-Term Outcomes of 68Ga-PSMA-11 PET/CT Imaging Evaluations for Patients With Prostate Cancer (Newly Diagnosed, Suspected Recurrence P or Are Candidates for Radioligand Therapy)
Telix Pharmaceuticals (Innovations) Pty Limited9 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Prostate Cancer Long Term Outcomes
研究概览
简要总结
The purpose of this observational research registry is to understand the real-world use of Illuccix PET/CT in prostate cancer, and how results from this testing impact patient's treatment and prostate cancer journey over time. It will follow subjects and the diagnostic testing and therapy they receive for their prostate cancer.
Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.
- •Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
- •Have undergone a 68Ga-PSMA-11 (Illuccix or Gozellix) PET/CT imaging evaluation within 60 days before enrolling in the study. (Prior imaging with alternate radioactive imaging agents are allowed, but enrollment imaging must be with 68Ga-PSMA-11(Illuccix or Gozellix).
- •Have histopathologically confirmed prostate adenocarcinoma.
- •Have a life expectancy of ≥ 6 months as determined by the investigator.
- •Participants intended for enrollment in Cohort 1: Patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation to evaluate potential spread of the disease.
- •Participants intended for enrollment in Cohort 2: Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11 PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels). Participants intended for enrollment in Cohort 3: Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.
- •Be willing and able to provide informed consent and comply with the protocol requirements.
排除标准
- •Participants are excluded from the study if any of the following criteria apply. All participants must NOT:
- •Have any medical condition or other circumstances that, in the opinion of the Investigator, compromises the safety of the participant, the ability of the participant to comply with protocol requirements, the ability of the participant to complete the study, or confound study outcomes by being unable to produce reliable data over the course of the study.
结局指标
主要结局
Prostate Cancer Long Term Outcomes
时间窗: 3 years
Long term outcomes of patients with newly diagnosed or recurrent disease prostate cancer or those being evaluated for radioligand therapy, who undergo 68Ga-PSMA-11PET/CT imaging for clinical management.
次要结局
- Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection(1.5 years)
- Patient Demographic and Clinical Characteristics(1.5 years)
- Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer(1.5 years)
- Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning(1.5 years)
- Differential Use across Racial and Ethnic Groups(3 years)
- Conventional Imaging(3 years)
研究者
研究点 (9)
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