Comparison of Ga-68 PSMA PET/CT and Multiparametric Prostate MRI for Lesion Detection in Cognitive Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinically Significant Prostate Cancer Detection Rate
研究概览
简要总结
Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. The diagnosis of prostate cancer is established through prostate biopsy, and several biopsy techniques have been developed in recent years.
Prostate biopsy can be broadly classified into systematic and targeted biopsy techniques. Systematic biopsy is performed under transrectal or transperineal ultrasound guidance without the use of prior imaging. Targeted biopsy techniques include cognitive biopsy, multiparametric magnetic resonance imaging (mpMRI) fusion biopsy, in-bore MRI biopsy, and robotic biopsy.
Cognitive biopsy is defined as the targeting of lesions identified on pre-biopsy imaging, usually multiparametric prostate MRI. MRI-fusion biopsy integrates mpMRI images with real-time ultrasound images, while in-bore biopsy is performed directly under MRI guidance. Although MRI-fusion biopsy is considered the gold standard technique, cognitive biopsy is more commonly used in developing countries due to lower cost and reasonable diagnostic accuracy.
Recently, Ga-68 prostate-specific membrane antigen (PSMA) PET/CT has become the gold standard imaging modality for staging prostate cancer after receiving FDA approval. PSMA is a type II transmembrane protein highly expressed on prostate cancer cells. PSMA PET/CT has high sensitivity and specificity for the detection, staging, and recurrence of prostate cancer.
Currently, multiparametric prostate MRI is commonly used to detect lesions before cognitive biopsy. However, there is no study in the literature evaluating the use of PSMA PET/CT imaging for guiding cognitive prostate biopsy.
In this retrospective single-center study, the investigators aim to compare the effectiveness of Ga-68 PSMA PET/CT and multiparametric prostate MRI as imaging modalities used prior to cognitive prostate biopsy.
详细描述
This retrospective study will include patients who underwent cognitive prostate biopsy at the Urology Department of Health Sciences University Fatih Sultan Mehmet Training and Research Hospital between 2020 and 2024.
Patient records will be reviewed retrospectively. The collected data will include:
Age PSA levels PSA density Prostate volume Prostate biopsy pathology results mpMRI PIRADS scores Ga-68 PSMA PET/CT imaging reports
Patients will be divided into two groups according to the imaging modality used prior to cognitive prostate biopsy:
Patients evaluated with multiparametric prostate MRI Patients evaluated with Ga-68 PSMA PET/CT
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40 years or older
- •Patients who underwent cognitive prostate biopsy between 2020 and 2024
- •Patients who had pre-biopsy imaging with multiparametric prostate MRI or Ga-68 PSMA PET/CT
- •Patients with available prostate biopsy pathology results
- •Patients with prostate lesions scored PIRADS 4 or 5 on multiparametric prostate MRI
排除标准
- •Patients with incomplete clinical or imaging data
- •Patients without available histopathological biopsy results
- •Patients who underwent prostate biopsy without pre-biopsy imaging
- •Patients with lesions scored PIRADS ≤3 on multiparametric prostate MRI
研究组 & 干预措施
mpMRI-guided Cognitive Biopsy
Patients who underwent cognitive prostate biopsy after lesion detection with multiparametric prostate MRI.
Ga-68 PSMA PET/CT-guided Cognitive Biopsy
Patients who underwent cognitive prostate biopsy after lesion detection with Ga-68 PSMA PET/CT imaging.
结局指标
主要结局
Clinically Significant Prostate Cancer Detection Rate
时间窗: Periprocedural (at the time of prostate biopsy)
Comparison of clinically significant prostate cancer detection rates between patients undergoing cognitive prostate biopsy guided by multiparametric prostate MRI and those guided by Ga-68 PSMA PET/CT.
次要结局
- Superiority of Ga-68 PSMA PET/CT-guided cognitive biopsy over mpMRI-guided biopsy in detecting prostate cance(Periprocedural (at the time of prostate biopsy))