NL-OMON52569招募中3 期
PSMA-PET guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer - PERYTO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 538
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Patients with prostate adenocarcinoma treated with radical prostatectomy;
- •Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009,
- •only with Gleason score available;
- •No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days)
- •without evidence of lymph node or distant metastases;
- •PSA progression after prostatectomy defined as two consecutive rises with the
- •final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured
- •at least 6 weeks after radical prostatectomy;
- •PSA at inclusion < 1.0 ng/mL;
- •WHO performance status 0-2 at inclusion;
- •Age at inclusion between 18 and 80 years;
- •Written (signed and dated) informed consent prior to registration.
排除标准
- •Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
- •Previous or concurrent active invasive cancers other than superficial
- •non-melanoma skin cancers;
- •Patients with positive nodes or with distant metastases based on the surgical
- •specimen of lymphadenectomy or the following minimum diagnostic workup:
- •PSMA-PET/CT or PSMA-PET/MRI, 60 days prior to registration;
- •Double-sided metallic hip prosthesis;
- •Inability or unwillingness to understand the information on trial-related
- •topics, to give informed consent or to fill out QoL questionnaires.
研究者
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