CTRI/2018/05/014054招募中3 期
Randomised controlled trial of Prostate Radiotherapy In high risk & node positive disease comparing Moderate & Extreme hypofractionation. - PRIME
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1.Participants must be histologically proven, adenocarcinoma prostate
- •2.Localised to the prostate or pelvic lymph nodes
- •3.High risk prostate cancer as per NCCN definition
- •clinical stage T3a or Gleason score 8/Gleason grade group4 or Gleason score 9-10/gleason grade group 5, PSA > 20 ng/mL.orVery high risk prostate cancer i.e T3b-T4 or Primary Gleason pattern 5/Gleason grade group 5 or > 4cores Gleason score8-10/Gleason grade group 4 or5
- •4.Ability to receive long term hormone therapy/ orchidectomy
- •5.KPS >70
- •6.No prior history of therapeutic irradiation to pelvis
- •7.Patient willing and reliable for follow-up and QOL
- •8.Signed study specific consent form
排除标准
- •1.Evidence of distant metastasis at anytime since presentation.
- •2. Life expectancy <2 year.
- •3. Previous RT to prostate or prostatectomy.
- •4. A previous trans-urethral resection of the Prostate(TURP).
- •5. Severe urinary symptoms or with severe IPSS score ( >15) inspite of being on hormonal therapy for 6months which in the opinion of the physician precludes RT.
- •6. Patients with known obstructive symptoms with stricture.
- •7. Any containdication to radiotherapy like inflammatory bowel disease.
- •8. Uncontrolled co-morbidities including, but not limited to diabetes or hypertension.
- •9. Unable to follow up or poor logistic or social support.
研究者
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