A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- Primary Objective
研究概览
简要总结
The goal of this observational research is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan.
Participants will be enrolled at their physician's office at the time of referral for PYLARIFY PET and will be followed for up to 5 years. Data concerning their prostate cancer diagnostics and treatment will be collected at 6-month intervals.
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
- •Patients must meet all the following inclusion criteria:
- •Biological male at birth ≥ 21 years of age
- •Histopathological confirmed prostate adenocarcinoma
- •Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:
- •Patients who are newly diagnosed with prostate cancer (and have suspected metastases per the physician's discretion per standard of care assessment) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET for identification of suspected metastases.
- •Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry
- •Life expectancy ≥ 6 months as determined by the investigator
- •Able and willing to provide informed consent and comply with the protocol requirements.
排除标准
- •Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study:
- •Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY
- •Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)
- •Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety of compliance of the patient to produce reliable data or completing the study.
研究组 & 干预措施
Cohort 1
Patients who are newly diagnosed with prostate cancer (and have suspected metastases) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET
干预措施: PYLARIFY (Diagnostic Test)
Cohort 2:
Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry
干预措施: PYLARIFY (Diagnostic Test)
结局指标
主要结局
Primary Objective
时间窗: 5 years
The objective of this registry is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan and for whom PYLARIFY imaging is incorporated into treatment recommendations and management plans.
次要结局
- Secondary Objective 2(5 years)
- Secondary Objective 3(5 years)
- Secondary Objective 1(5 years)
- Secondary Objective 5(5 years)
- Secondary Objective 4(5 years)