An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Biochemical Recurrence-free Survival
研究概览
简要总结
The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?
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
- •Diagnosed as prostate cancer pathologically by prostate biopsy
- •Evaluated as localized prostate cancer by imaging studies
- •Prostate volume>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
- •Gleason score≤ 4+3=7
- •Preoperative PSA<20ng/mL
- •Estimated survival> 10 years；
- •Informed consent is obtained from the patient
排除标准
- •The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
- •Any contraindication of surgery or anaesthesia
结局指标
主要结局
Biochemical Recurrence-free Survival
时间窗: 5 years
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater.
次要结局
- Surgical time(Intraoperative)
- Continence(2 weeks, 1 months, 3 months, 6 months, 12 months after surgery)
- Positive surgical margin rate(Through study completion, an average of 5 year)
- Complication(Through study completion, an average of 5 year)
- Cancer-specific survival(From date of randomization until the date of date of death from cancer, assessed up to 60 months)
- Estimated blood loss(Intraoperative)
- Hospital stay(From date of surgery until the date of discharge, an average of 7 days)
- Lower urinary tract symptoms(1 months, 3 months, 6 months, 12 months after surgery)
- Erectile function(6 months, 12 months and 24 months after surgery)
- Overall survival(From date of randomization until the date of date of death from any cause, assessed up to 60 months)
研究者
Yonghong Li
Professor
Sun Yat-sen University