Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.
研究概览
简要总结
Retrospective monocentric analysis performed on patients treated with salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 60 Years 至 86 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patient treated by S-HIFU for a single recurrence within the prostatic bed after an initial RP with curative intent with or without lymphadenectomy followed by salvage or adjuvant EBRT (with or without pelvic lymph node irradiation) combined or not with ADT;
- •life expectancy of ≥10 years;
- •histological local recurrence (positive biopsy),
- •negative metastatic evaluation (All patients underwent multiparametric MRI (mpMRI) to confirm the relapse in the prostatic bed and Choline PET/CT to exclude metastasis (lymph node, visceral or bone metastasis).
- •the use of ADT at BF after S-EBRT was not an exclusion criterion (ADT was introduced by the centre referring the patient).
- •no limits were placed on prostate cancer characteristics, PSA (value, doubling time (PSA-DT)), Gleason score and location of suspected recurrence in relation to the sphincter.
排除标准
- •patients who do not meet the inclusion criteria
结局指标
主要结局
Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.
时间窗: December 31, 2019
Oncological outcomes: * Treatment failure-free survival: absence of: * recurrent prostate cancer in the prostatic bed and/or * metastasis and/or * introduction of systemic treatment * Progression-free survival: absence of: * metastasis and/or * introduction of systemic treatment * decrease in PSA value: any drop in PSA after S-HIFU, regardless of whether there was subsequent PSA progression * BCR-free survival following S-HIFU defined as an absence of two rises in PSA ≥0.2 ng/mL above nadir Functional outcomes: * complications (Clavien classification) * Urinary incontinence (Ingelman-Sundberg score)
次要结局
未报告次要终点