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临床试验/NCT07485257
NCT07485257已完成不适用

Molecular Profiling of Prostate Cancer Lesions With MRI-PSMA PET Discordance

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Identification of omic alterations distinguishing MRI-PSMA PET discordant lesions from concordant lesions within the same cohort.

研究概览

简要总结

MRI and PSMA-PET are highly sensitive imaging tools for prostate cancer, yet they often detect different lesions. These discordant findings pose clinical uncertainty because their biological significance is unclear. This project aims to molecularly characterize MRI-PSMA PET discordant lesions using high-quality biobanked samples from patients enrolled in an institutional study (NCT06187870). By integrating imaging and molecular data, the study will clarify whether these lesions represent indolent disease, aggressive subclones, or biologically distinct entities, and will assess their clinical implications.

详细描述

Magnetic Resonance Imaging and PSMA-PET are currently the most sensitive imaging modalities for prostate cancer, yet they do not always provide concordant results. Discordant lesions, those detected by one modality but not the other, represent a significant clinical challenge, as their biological nature and implications remain poorly understood. A molecular characterization of these lesions may clarify whether they correspond to indolent clones missed due to imaging limitations, aggressive subclones with distinct molecular features, or biologically different disease entities. We aim to investigate prostate cancer lesions that are discordant between MRI and PSMA-PET, with the specific objective of elucidating their molecular characteristics and clinical implications. Molecular omic analyses will be performed on existing biobank samples from patients enrolled at our institution who have already provided informed consent for research use. This resource provides access to high-quality biospecimens linked with imaging data, enabling a comprehensive evaluation of MRI-PSMA PET discordant prostate cancer lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Signed informed consent
  • PCa diagnosis
  • Available samples
  • Performed both PSMA PET and MRI

排除标准

  • Low quality samples availability

结局指标

主要结局

Identification of omic alterations distinguishing MRI-PSMA PET discordant lesions from concordant lesions within the same cohort.

时间窗: At the time of biopsy

Distribution of molecular profiles across discordant versus concordant lesions.

时间窗: At the time of biopsy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Alberto Briganti

Full professor

IRCCS San Raffaele

研究点 (1)

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