177Lu-PSMA As a Systemic Adjuvant Treatment in Patients with High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Treatment effectiveness
研究概览
简要总结
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy
详细描述
The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.
The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy
Participation time in the Study:
intervention phase - 1 day; observation phase - 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Giving a written informed consent
- •Histopathologically confirmed high or very high risk prostate cancer
- •Completion of radical locoregional treatment
- •Completion of locoregional treatment within 3 months before inclusion to the study
- •ECOG performance status 0 to 2
- •Age over 18 years
- •Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
- •Castrate testosterone level (testosteron < 50 ng/dL lub 1,7 nmol/L)
- •Patients with adequate function of main organs:
- •bone marrow:
- •neutrophils > 1500x10^9/L;
- •thrombocytes > 100,000x10^9/L;
- •hemoglobin > 9 g/dL
- •bilirubin < 2xULN (upper limit of normal) in patients with Gilbert's syndrome < 5xULN;
- •aminotransferase < 3xULN
- •eGFR > 50 ml/min
- •albumin >2.5 mg/ml
- •For men of reproductive age: the need to use double barrier contraception
排除标准
- •The presence of distant metastases confirmed by radiological examination
- •Absence of approval to use effective contraception method
- •Absence of Patient's consent to participate in the Study
- •Urinary tract obstruction or/and hydronephrosis.
- •Concurrent anticancer treatment.
研究组 & 干预措施
Experimental
The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy
干预措施: Lutetium (177Lu) vipivotide tetraxetan (Drug)
结局指标
主要结局
Treatment effectiveness
时间窗: 2 and 5 years after end of treatment
Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng/mL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later
次要结局
- Biochemical progression-free survival(During the intervention and follow up period (assessed up to 5 years))
- Radiological progression-free survival(During the intervention and follow up period (assessed up to 5 years))
- Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0(During the intervention and follow up period (assessed up to 5 years))
- Quliaty of life(During the intervention and follow up period (assessed up to 5 years))
- Time until the next therapeutic intervention(During the intervention and follow up period (assessed up to 5 years))