Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Disease-free rate
研究概览
简要总结
The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP).
Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).
详细描述
Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. A recent systematic review assessed a total of 32 studies of SCAP (5.513 patients). The overwhelming majority of patients (93%) received whole-gland SCAP. The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 67.49% (95% CI: 61.68-72.81%), and for 5-year BCR-free survival was 50.25% (95% CI: 44.10-56.40%).
Nevertheless, the evidence base relating to the use of SCAP is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when these studies are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority only refer to biochemical-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting.
Due to this lack of evidence, the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated with PET/PSMA (if not available then Fluciclovine PET/CT or choline PET/CT must be performed).
- •Life expectancy >10 years
- •Prostate volume < 100cc
- •PSA<10 ng/mL
- •mpMRI + fusion/systematic biopsy ≤cT3a without affecting the bladder neck or the membranous urethra
排除标准
- •Patients with clinically confirmed distant metastasis
- •Any previous major rectal surgery
- •Clinically significant lower urinary tract or rectal anomalies
- •Existing urethral, rectal, or bladder fistulae
结局指标
主要结局
Disease-free rate
时间窗: 1 year
absence of disease in follow-up biopsy AND PET/PSMA
ADT-free survival
时间窗: 5 years
Absence of androgen deprivation therapy need during follow-up
次要结局
- Effect on urinary symptoms(1 year)
- Rate of incontinence(1 year)
- Rate of sexual disfunction(1 year)
- Biochemical free survival(5 years)
- Metastasis free survival(5 years)
- Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.(1 year)
- Rate of metastasis detected by PET-CT(1 year)
研究者
Ignacio Puche Sanz
MD PhD
University Hospital Virgen de las Nieves