Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients with high volume mCSPC having PSMA avid disease
研究概览
简要总结
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.
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
- •Male, age ≥ 18 years
- •Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
- •Poor risk patients with mCSPC at study enrollment
- •De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
- •High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
- •Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
- •No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
- •Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility
排除标准
- •Under a randomized-controlled trial with unknown allocation of systemic therapy
- •Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
- •Unable to provide written consent by patient and their legal representatives
- •In the opinion of the treating physician:
- •conditions which would significantly impair the patient's ability to comply with study procedures and follow up
- •Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging
- •another active malignancy
- •patient on dialysis
- •another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging
研究组 & 干预措施
PSMA and FDG PET Imaging
Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.
干预措施: Ga 68 PSMA-11 PET (Diagnostic Test)
PSMA and FDG PET Imaging
Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.
干预措施: 18F-DCFPyL PET (Diagnostic Test)
PSMA and FDG PET Imaging
Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.
干预措施: FDG PET (Diagnostic Test)
结局指标
主要结局
Proportion of patients with high volume mCSPC having PSMA avid disease
时间窗: 5 years
次要结局
- Proportion of patients with PSMA-/FDG+ discordant lesions(5 years)