Ablative Therapy in the Management of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prostate biopsy Gleason grade
研究概览
简要总结
The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.
详细描述
Through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
- •Have received prior focal therapy
排除标准
- •Clinically-evident metastatic disease
- •Unable to fill out an English-language questionnaire
结局指标
主要结局
Prostate biopsy Gleason grade
时间窗: 12 months
Will be obtained through patient biopsy pathology results
次要结局
- Patient characteristics/demographics(12 months)
- MRI PI-RAD grade(12 months)
- Lab results - PSA level(12 months)
- Patient-reported quality of life: MSHQ-EjD(12 months)
- Patient-reported quality of life: EPIC-26(12 months)
- Patient-reported quality of life: IIEF-5(12 months)
- Patient-reported quality of life: IPSS(12 months)