EUCTR2016-001815-19-AT进行中（未招募）1 期
An open-label, single-arm, rater-blinded, multicenter phase 1/2 study to assess safety and diagnostic accuracy and radiotherapeutic implications of pre-operative Ga-68-PSMA-11 PET/CT imaging in comparison to histopathology, in newly-diagnosed prostate cancer (PCA) patients at high risk for metastasis, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND). - Ga-68-PSMA-11 in high-risk prostate cancer
Deutsches Krebsforschungszentrum (DKFZ), Stiftung des öffentlichen Rechts0 个研究点目标入组 173 人开始时间: 2018年3月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 173
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
- •1.Written informed consent.
- •2.Male = 18 years of age.
- •3.Histologically confirmed adenocarcinoma of the prostate.
- •4.High risk for metastasis, defined by either:
- •a.stadium cT3 according to TNM classification, or
- •b.Gleason Score >7, or
- •c.PSA >20 ng/mL.
- •5.Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7-60 days after start of the study.
- •6.Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
- •7.Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.
- •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 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 86
排除标准
- •1.Known hypersensitivity to Ga-68-PSMA-11 or its components.
- •2.Presence of known lymph node metastases outside surgical field.
- •3.More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
- •4.Previous prostate cancer therapy.
- •5.Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
- •6.Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
- •7.Evidence of neuroendocrine small cell carcinoma.
- •8.Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
- •9. Simultaneous participation in other clinical trials.
研究者
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