China Medical University Hospital, Taichung, Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- biochemical outcome
研究概览
简要总结
To evaluate the cancer control for prostate cancer patients treated with focal therapy.
详细描述
Traditional treatments for localized prostate cancer are radical prostatectomy and radiotherapy. However, they would carry side effects including urinary incontinence, sexual dysfunction, radiation cystitis and proctitis, leading to great impact on quality of life. Focal therapy of is another emerging treatment strategy for localized prostate cancer. It aims on ablation of the tumor with sparing of healthy prostatic tissue in order to minimize the injury to urinary and sexual function. Besides, owing to the improvement of multiparametric magnetic resonance imaging (mpMRI), the investigators can localize the prostate cancer more precisely and the accessibility of focal therapy is also increased.
Literature showed focal ablation of HIFU or cryotherapy for low and intermediate-risk prostate cancer patients yielded in brilliant outcomes. Biopsy in post-treatment one year showed 87% and 94.6% were negative for clinically significant cancer, respectively. Up to 92% of patients did not need salvage treatment in two years. Ninety-one to one hundred precent of patients had no urinary incontinence, and 74% and 81.5% had no erectile dysfunction, respectively.
This prospective study aims to evaluate the cancer control and quality of life for prostate cancer patients treated with focal therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •biopsy-proven unilateral prostate cancer, the other side insignificant cancer (Gleason 6 or less and maximal cancer core length 4mm or less) is allowed
- •clinical T2a or less
- •Gleason 4+3 or less
- •serum PSA less than 20 ng/mL
排除标准
- •T2b or higher
- •Gleason 4+4 or higher
- •serum PSA 20 or higher
- •lymph node or distant metastasis
- •previous treatment with prostatectomy, radiotherapy, androgen deprivation therapy, HIFU, or cryoablation
结局指标
主要结局
biochemical outcome
时间窗: 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
change of Prostate Health Index (PSA, free PSA, and p2PSA will be combined to report PHI)
oncological outcome
时间窗: 6 months
MR/US fusion prostate biopsy to see if there is recurrent cancer
次要结局
- Functional outcome(1 month, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months)
研究者
Po-Fan Hsieh
Attending Urologist, Department of Urology, China Medical University Hospital
China Medical University Hospital