DRKS00022915招募中3 期
Image-guided focal dose escalation in patients with primary prostate cancer treated with primary external beam hypofractionated radiation therapy (HypoFocal) – a prospective, multicenter, randomized phase III study. - HypoFocal-SBRT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 374
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- •2. Primary localized PCa (cN0 and cM0 in mpMRI and PSMA-PET):
- •- high- or very high-risk according to NCCN v2.2021 (see 20.3)
- •- unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3)
- •3. Signed written informed consent for this study
- •4. Age >18 years
- •5. Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
- •6. ECOG Performance score 0 or 1
- •7. IPSS Score =15
- •8. Prostate volume = 75 ml at RT planning
排除标准
- •1. Evidence of neuroendocrine tumor cells
- •2. Prior radiotherapy to the prostate or pelvis
- •3. Prior radical prostatectomy
- •4. Prior focal therapy approaches to the prostate
- •5. Time gap between the beginning of ADT and conduction of mpMRI and PSMA-PET scans is >1 month
- •6. Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA-PET/CT
- •7. Evidence of metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
- •8. Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
- •9. PSA >30 ng/ml prior to starting ADT
- •10. Expected patient survival <5 years
- •11. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
- •12. Contraindication to undergo a mpMRI scan
- •13. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
- •14. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
- •15. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
- •16. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
- •17. In mpMRI and PSMA-PET/CT or PSMA-PET/MRI scans no visible tumor
- •18. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •19. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- •21. Known or persistent abuse of medication, drugs or alcohol
- •22. Patients expected to have severe set up problems
- •23. Dose constraints for organs at risk cannot be adhered to
研究者
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