NL-OMON56327招募中3 期
Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0 - Hypo-FLAME 3.0
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 352 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 352
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
- •No evidence of lymph node or distant metastases N0M0.
- •MRI visible tumor on mpMRI (PI-RADS v2 >= 4).
- •Intermediate- or high-risk PCa, defined as at least one of the following risk
- •- clinical stage cT2c-T3a (UICC TNM 8th edition) [13]
- •- Imaging stage T2c, T3a or T3b with less than 5 mm invasion in the seminal
- •vesicles (as defined on mp MRI)
- •- >= Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
- •- PSA >= 20 ng/mL
- •World Health Organization (WHO) performance score <= 2
- •International prostate symptoms score (IPSS score) < 15
- •PSA <= 30 ng/mL
- •Prostate volume <= 90 cc on MRI
- •Ability to give written informed consent and willingness to return for follow*
排除标准
- •Prior pelvic radiotherapy
- •TURP (transurethral prostate resection) within 6 months from start treatment
- •On-line image guidance based on either fiducial markers or high-quality CBCT
- •or MRI according to local guidelines not feasible. For example: Unsafe to have
- •gold fiducial marker implantation, if gold fiducial markers are used for image
- •guidance. Distorted images on MR because of hip protheses prohibit accurate MR
- •image guidance, if MR is used for image guidance.
- •Contraindications to MRI according to local hospital guidelines
研究者
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