NL-OMON53873招募中2 期
A pilot study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL - Destination
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 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
- 20
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
- •1. Men aged >=18 years 2. Histological confirmation of prostate adenocarcinoma
- •requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups
- •1, 2 or 3) 4. MRI stage T2 or less (as staged by AJCC TNM 2018) 5. MRI-visible
- •tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging
- •and/or dynamic contrast-enhanced imaging with concordant pathology 6. Dominant
- •lesion <50% of prostate on any axial slice and <50% total prostate volume 7.
- •PSA <20 ng/ml prior to starting ADT 8. Patients can be concurrently treated
- •with androgen deprivation therapy if this would be standard of care. LHRH
- •analogues or Bicalutamide are permitted. ADT is not mandatory where this would
- •usually be omitted. 9. WHO Performance status 0-2 10. Ability of the
- •participant understand and the willingness to sign a written informed consent
- •form. 11. Ability/willingness to comply with the patient reported outcome
- •questionnaires schedule throughout the study.
排除标准
- •1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant,
- •claustrophobia) 2. IPSS 19 or higher 3. High grade disease (GG3) occult to
- •MRI-defined lesion 4. Post-void residual >100 mls, where known 5. Prostate
- •volume >90cc 6. Comorbidities which predispose to significant toxicity (e.g.
- •inflammatory bowel disease) or preclude long term follow up 7. Unilateral or
- •bilateral total hip replacement, or other pelvic metalwork which causes
- •artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9.
- •Patients needing >6 months of ADT due to disease parameters. 10. Previous
- •invasive malignancy within the last 2 years excluding basal or squamous cell
- •carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming
- •cystoscopic follow up now negative) or small renal masses on surveillance
研究者
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