NCT03525288进行中（未招募）2 期
PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer
Centre hospitalier de l'Université de Montréal (CHUM)4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年5月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Failure-free survival
研究概览
简要总结
PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
- •Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
- •Charlson Cormobidity Index ≤ 4
- •High-risk of distant metastases as defined by any of:
- •Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour.
- •Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-
- •Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or>0.2ng/ml-RP)
- •Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
排除标准
- •Prior androgen deprivation therapy terminated < 12 months prior to enrollment.
- •Prior or planned PET scan.
结局指标
主要结局
Failure-free survival
时间窗: 5 years
Time to failure event
次要结局
- Detection yield of PSMA PET imaging(2 years)
- Acute and delayed toxicities(5 years)
- Rate of failure(5 years)
- Survival(5 years)
- Health-related quality of life(5 years)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and ReproducibilityProstate CancerNCT03486886Centre hospitalier de l'Université de Montréal (CHUM)29
尚未招募
不适用
Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET StudyProstate Cancer MetastaticProstate Cancer Metastatic to BoneProstate NeoplasmProstate CancerOligometastatic DiseaseOligometastasisNCT06430411Medical University of Vienna500
Unknown
2 期
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer PatientsProstate CancerNCT03344822Central Hospital, Nancy, France33
已完成
不适用
68Ga-PSMA PET/CT Imaging in Assessment of Prostate CancerPET/CTProstate Specific Membrane AntigenIMAGENCT05134064RenJi Hospital66
已完成
不适用
Role of PSMA-PET/MRI for diagnosis and follow-up of focal therapy of prostate cancerC61Malignant neoplasm of prostateDRKS00022363niversitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie15