Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
研究概览
简要总结
This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:
- PSMA PET with calculation of SUVmax and PRIMARY-Likert score
- Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
- Immunohistochemistry on diagnostic prostate biopsies
- Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
- •Non-metastatic status at study inclusion (patient enrollment).
- •No prior or concomitant androgen deprivation therapy
- •Ability to understand a written informed consent and willingness to sign it.
排除标准
- •Unable to tolerate a PSMA-PET scan
- •Unwillingness to be managed with AS
- •Receipt of neoadjuvant or curative-intent therapies
- •Pacemaker
- •Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
研究组 & 干预措施
single arm
All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo:
- PSMA-PET/MRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score).
- Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies.
Confirmation biopsy one year after diagnosis, according to international guidelines.
干预措施: mpMRI-targeted confirmatory biopsy (Procedure)
结局指标
主要结局
Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
时间窗: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS).
次要结局
未报告次要终点
研究者
Giorgio Gandaglia
Medical Doctor
Università Vita-Salute San Raffaele