NCT04231006招募中不适用
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time to castration-resistant prostate cancer
研究概览
简要总结
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
详细描述
The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.
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
- •Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
- •≥ 2 years since the end of primary radiotherapy
- •PSA recurrence Phoenix criteria (nadir + 2)
- •No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
- •MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
- •GTV identifiable on mpMRI
- •No current endocrine therapy
- •Plasma testosterone ≥1.75 nm/l
- •PSA doubling time ≥ 6 months and ≤ 24 months
- •Performance status 0-1
- •DAN PSS score ≤ 20
- •Maximal urinary flow ≥ 10 ml/s
- •Life expectancy > 5 years
- •PSA ≤ 10 ug/L at recurrence
排除标准
- •Pubic arc interference or major calcifications within the prostate gland.
- •Contraindication for spinal or general anaesthesia.
- •Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
- •Inflammatory bowel disease
- •Contraindications to 3T MRI
- •eGFR < 30 ml/min
- •≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
结局指标
主要结局
Time to castration-resistant prostate cancer
时间窗: 10 years
The time from intervention until the prostate cancer becomes castration resistant
次要结局
- Erectile dysfunction(5 years)
- Urinary symptoms(5 years)
- Bowel symptoms(5 years)
研究者
Simon Buus
Principal investigator
Aarhus University Hospital
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Focal Salvage HDR Brachytherapy for the Treatment of Prostate CancerProstate CancerNCT01583920Sunnybrook Health Sciences Centre60
已完成
不适用
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using VitesseInterstitial RadiationHigh Dose Rate BrachytherapyUltrasound-based Planning Compared to CT-based PlanningProstate CancerNCT01248741British Columbia Cancer Agency20
招募中
不适用
Focal Brachytherapy for localized prostate cancer diagnosed by saturation biopsyprostate cancerJPRN-UMIN000044790ara Medical University35
招募中
2 期
Hemiablative Focal Brachytherapy Pilot StudyProstate CancerNCT02643511St George Hospital, Australia20
进行中（未招募）
不适用
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate CancerProstate Cancer RecurrentNCT02560181Sunnybrook Health Sciences Centre30