Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
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
- 1
- 主要终点
- Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points)
研究概览
简要总结
The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.
详细描述
Prostate cancer is the second most common cancer among men in Poland. Currently, a large number of diagnosed patients undergo radical radiotherapy. Despite the high effectiveness of treatment, some patients experience failures in the form of regional and / or distant metastases, most often in the form of isolated local recurrence. In patients with suspected local recurrence, we can decide on emergency treatment after PET, pelvic MRI with an assessment of the prostate gland, and after excluding metastases. The oncological(NCCN ) and urological (EUA) recommendations allow salvage surgical treatment, observation, palliative pharmacological castration, or treatment using salvage brachytherapy.
Salvage surgical treatment is associated with a 30-65% chance of cure in the top cancer centers in the world, and the risk of significant toxicity ranges from 17 to 48%.
Treatment with brachytherapy, due to the intra-tissue nature and the short therapeutic range of radiation, can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs, e.g., rectum and/or bladder. Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65% of patients, according to the prospective study RTOG 0526. However, emergency treatment in this study was associated with a 14% risk of significant post-treatment toxicity requiring medical intervention. There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland (focal brachytherapy), but they are only retrospective. They show significant treatment efficacy and lower toxicity.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)
- •Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
- •Exclusion of distant metastases using CT, MR, or PET imaging
- •PSA doubling time over six months
- •PSA value <10 ng / ml
- •No anti-androgen treatment in the year prior
- •Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points
- •General condition according to the WHO scale ≤ 2
- •Signing informed consent to participate in the study
排除标准
- •PSA value> 10ng / ml
- •General condition according to the WHO scale> 2
- •Dysuria on the IPSS scale> 20 points
- •PSA doubling time <6 months
- •Inability to discontinue anticoagulants.
- •An active urinary tract infection.
- •Contraindications to general anesthesia
- •Active inflammatory bowel diseases.
- •Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
- •Estimated Survival <5 years
研究组 & 干预措施
Experimental
Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points)
时间窗: change from baseline to 24 months of follow-up
Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5): scale 0-25 points
Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale
时间窗: change from baseline to 24 months of follow-up
Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale - IPSS within 0-35 points
Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points)
时间窗: change from baseline to 24 months of follow-up
Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols, scale: 0-100 points
次要结局
- Assessment of the adverse events in the percentage of grades with the CTCAE v4.0(24 months after treatment)