EUCTR2021-000123-12-DK进行中（未招募）1 期
PRISMA-PET – Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging. - PRISMA-PET
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Men with a newly diagnosed intermediate or high risk (including locally advanced) prostate cancer or low risk with a clinical suspicion of
- •metastases based on other findings, and before any treatment is initiated.
- •Has given informed consent to participate
- •Can read and understand provided patient information material in
- •Biopsy verified, newly diagnosed and untreated PCa
- •Any, some, or all of the following features:
- •o PSA = 20 ng/ml OR
- •o Gleason Score = 4+3 OR
- •o Tumor stage cT2c or above as determined by digital rectal exploration
- •and/or transrectal ultrasonography OR
- •o Suspicion of metastases as judged clinically
- •Staging by imaging is warranted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 298
排除标准
- •Consent not given
- •Inability to read and/or understand provided patient information in
- •Previously given consent to this study withdrawn for any reason
- •Staging by imaging not warranted as judged clinically
- •Allergy towards NaF, PSMA or other contents in the solutions
研究者
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