CTIS2022-502373-42-00招募中1 期
Metastasis-directed therapy for oligorecurrent prostate cancer : A randomized phase III trial. - S65935
Z Leuven0 个研究点目标入组 873 人开始时间: 2023年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 873
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 65+（—）
- 性别
- Male
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures., Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol., Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board. All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures., Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner., Histologically proven initial diagnosis of prostatic adenocarcinoma., Priory treated and controlled primary tumor., Biochemical recurrence defined by prostate-specific antigen (PSA) values >0.2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT., Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET. Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5., Serum testosterone level within normal range., WHO performance 0-2, Age >= 18 years old
排除标准
- •Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol, Not able to understand the treatment protocol or sign informed consent., Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial., Participation in an interventional Trial with an investigational medicinal product (IMP) or device., Serum testosterone level at castration level., PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)., Presence of poly-metastatic disease, defined as more than 5 metastatic lesions., Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial., Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible., Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade >2 or a thromboembolic event).
研究者
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