2022-502373-42-00招募中3 期
Metastasis-directed therapy for oligorecurrent prostate cancer : A randomized phase III trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 873
- 试验地点
- 11
- 主要终点
- Poly-metastatic free survival will be calculated from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT/MRI. In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of an irradiated site and/or clinical symptoms caused by local progression.
研究概览
简要总结
The aim is to investigate whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to MDT significantly prolongs PMFS and/or mCRPC-FS. Metastatic castration-refractory prostate cancer free survival (mCRPCFS) will be calculated from the last day of MDT until the first day of diagnosis of castration-resistant prostate cancer (CRPC). CRPC is defined according to the contemporary EAU-guidelines as the time to biochemical and/or clinical progression at castrate testosterone levels (< 50 ng/dl). BcR is defined as two consecutive PSA rises (1 week interval), each with a value ≥ 25% increase above the nadir PSA level after treatment, and both with a PSA higher than the baseline PSA at inclusion in the study.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
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
- •Serum testosterone ≥ 50 ng/dl or 1.7 nmol/L (above castration level).
- •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 (< 50 ng/dl or 1.7 nmol/L).
- •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).
结局指标
主要结局
Poly-metastatic free survival will be calculated from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT/MRI. In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of an irradiated site and/or clinical symptoms caused by local progression.
Poly-metastatic free survival will be calculated from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT/MRI. In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of an irradiated site and/or clinical symptoms caused by local progression.
次要结局
- Metastatic castration-refractory prostate cancer free survival (mCRPC-FS). mCRPC-FS will be calculated from the last day of MDT until the first day of diagnosis of castration-resistant prostate cancer (CRPC). CRPC is defined according to the contemporary EAU-guidelines as the time to biochemical and/or clinical progression at castrate testosterone levels (< 50 ng/dl).
- Biochemical progression-free survival (bPFS) will be calculated from the last day of the first SBRT or from the day metastasectomy was performed until the first day of biochemical relapse (BcR). BcR is defined as two consecutive PSA rises (1 week interval), each with a value ≥ 25% increase above the nadir PSA level after treatment, and both with a PSA higher than the baseline PSA at inclusion in the study. Patients free from BCR are censored at their last follow-up.
- Clinical progression free survival (cPFS) will be calculated from the last day of MDT until the first day of progression (local, nodal or metastatic) on PSMA PET-CT/MRI. Imaging is performed in case of BcR. Progression on PSMA PET-CT/MRI will be defined as in the consensus statements on PSMA PET-CT/MRI response assessment criteria in prostate cancer.
- Cancer specific survival (CSS) will be calculated from last day of treatment until PCa death.
- Overall survival (OS) will be calculated from last day of treatment until death from any cause.
- Acute and late toxicity as a result of radiotherapy will be scores using the Common Toxicity Criteria Version 5.0 (30). Toxicity will be scored at every follow-up visit.
- Quality of life scoring using the EORTC QLQ-C30 supplement with QLQPR25. We will assess the quality-of-life-years with the EuroQOL classification system (EQ-5D-5L). Assessments are planned at baseline, last day of treatment, and during follow-up consultation at month M1, M3, M6, M12 and M24.
研究者
Co-Investigator
Scientific
UZ Leuven
研究点 (11)
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