NL-OMON49965招募中2 期
Hypofractionated Focal Lesion Ablative Microboost in prostate cancer 2.0 - Hypo-FLAME 2.0
niversitair Ziekenhuis Leuven0 个研究点目标入组 83 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
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
- •- Men >= 18 years with histologically confirmed prostate adenocarcinoma
- •- Intermediate- or high-risk PCa, defined as at least one of the following risk
- •- Clinical stage: T2b, T2c, T3a or T3b with less than 5 mm invasion in the
- •seminal vesicles (defined on MRI) N0 M0
- •- Gleason sum score >= 7
- •- PSA >= 10 ng/mL.
- •- Prostate tumor nodule visible on mpMRI
- •- Ability to give written informed consent and willingness to return for
排除标准
- •- Prior pelvic radiotherapy or transurethral prostate resection
- •- Unsafe to have gold fiducial marker implantation, if gold fiducial markers
- •are used for image guidance (non MR-linac)
- •- Contraindications to MRI according to the Radiology Department guidelines
- •(metal implants, non-compatible cardiac device, allergy to gadolinium, severe
- •renal dysfunction or severe claustrophobia)
- •- World Health Organization (WHO) performance score > 2
- •- International prostate symptoms score (IPSS score) >= 15
- •- PSA > 30 ng/mL
研究者
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