Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 201
- 试验地点
- 10
- 主要终点
- 1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
研究概览
简要总结
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET/CT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.
详细描述
Prostate cancer is the most common malignancy in men and demonstrates heterogeneous clinical behavior. While many low-risk patients have indolent disease, a subset harbors clinically significant prostate cancer (csPCa) requiring early intervention. Active Surveillance (AS) is widely used to avoid overtreatment; however, current selection criteria-PSA, DRE, biopsy Gleason score, number of positive cores, PSA density, and mpMRI-lack sufficient predictive accuracy. Studies indicate that up to 30% of patients classified as low-risk by biopsy are found to have higher-grade disease at radical prostatectomy. The Istanbul PSMA PET/CT Criteria (IPPC) were developed by a multidisciplinary expert panel in Turkey to classify intraprostatic lesions on delayed (120-minute) Ga-68 PSMA PET/CT imaging into three risk categories:
- IPPC 1 No or homogeneous low uptake - safe for monitoring.
- IPPC 2: Indeterminate uptake - AS with close follow-up.
- IPPC 3: Focal, lentiform, high SUVmax ≥12 uptake in peripheral zone - definitive treatment recommended.
This study will evaluate the diagnostic performance of IPPC compared to standard mpMRI and biopsy findings, using radical prostatectomy pathology or long-term clinical follow-up as the reference standard.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •mpMRI performed within 3 months prior to enrollment
- •Systematic or MRI-targeted prostate biopsy performed
- •Biopsy-confirmed ISUP Grade 1 low-risk PCa
- •Prostate biopsy report specifying tumor localization and number of positive cores
- •Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd >0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores
- •Life expectancy ≥10 years
- •No prior PSMA PET imaging
- •No evidence of extra-prostatic disease on mpMRI
- •Signed informed consent for study procedures
排除标准
- •High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)
- •Prior prostate cancer treatment or prostate surgery
- •MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
- •History of pelvic radiotherapy
- •Life expectancy <10 years
- •Severe renal impairment
- •Inability to comply with follow-up schedule
结局指标
主要结局
1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
时间窗: Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for IPPC classification in identifying csPCa, defined as ISUP Grade Group ≥2 on radical prostatectomy pathology or disease progression on long-term follow-up.
次要结局
- Reduction in Repeat Biopsy Rate(Assessed over 2 years.)
研究者
Levent Kabasakal
Professor of Nuclear Medicine, Medical Doctor
Istanbul University - Cerrahpasa