Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Delay between the initial diagnosis and date of salvage treatment
研究概览
简要总结
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
详细描述
Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.
Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).
Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.
Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.
Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.
排除标准
- •systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.
结局指标
主要结局
Delay between the initial diagnosis and date of salvage treatment
时间窗: through study completion, up to 36 months
Delay between the initial diagnosis and date of salvage treatment
次要结局
- IPSS evaluation(12, 24, 36 months)
- PSA evaluation(3, 6, 12, 18, 24, 30, 36 months)
- Acute and late toxicity(3, 6, 12, 18, 24, 30, 36 months)
- IIEF5 evaluation(12, 24, 36 months)
- Birads score evaluation(12, 24, 36 months)