NL-OMON50844招募中3 期
18F-fluciclovine PET/CT and 18F-DCFPyL PET/CT in patients with biochemical recurrence of disease after radical prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. - RENARD trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Age >= 18 years.
- •*Histopathological confirmed prostate adenocarcinoma per original diagnosis.
- •*History of RARP.
- •*Biochemical recurrence of prostate cancer based on two consecutive measurable
- •PSA levels of 0.2 -2.0 ng/mL.
- •*Ability to understand and sign the written informed consent form.
- •*Patients who can undergo all study procedures per investigator*s point of
排除标准
- •*Another active malignant tumor, except skin basal cell carcinoma.
- •*pN1 disease after ePLND.
- •*Any change in prostate cancer treatment between both PET/CT scans.
- •*History of previous salvage therapies (including salvage radiotherapy or
- •salvage lymph node dissection).
- •*History of salvage radiotherapy of the prostate bed.
- •*History of cryotherapy, high-intensity focused ultrasound (HIFU).
- •*Treatment with androgen deprivation therapy (ADT) in the past 30 days or
- •*Unable to lie supine or still for imaging.
- •*Known allergy to investigational or reference products or to any excipients.
- •*Unable to provide written consent (linguistic or psychological inability).
- •*Uncooperative, in the Investigator*s opinion.
研究者
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