2023-504912-13-00招募中2 期
177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment with locoregional teleradiotherapy and hormone therapy.
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年9月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The assessment of biochemical failure ratio.
研究概览
简要总结
Assessment of treatment failure - the assesment of biochemical progression ratio, defined (according to the Phoenix criteria) as a rise of PSA by 2 ng/mL or more above the nadir (defined as the lowest PSA achieved after treatment), proven by a consecutive examination performed at least 4 weeks later.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven high-risk or very-high-risk prostate cancer (according to NCCN v1.2023): 1) high-risk patients: clinical advancement stage cT3a, or 4 or 5 ISUP grading group (with no leading Gleason 5 component), or PSA >20 ng/mL; lack of very-high-risk signs 2) very-high-risk patients: Clinical advancement stage cT3b-cT4, or ISUP 5 grading main group (with leading Gleason 5 component), or 2 or 3 features of high-risk, or >4 cores with 4 or 5 risk group in biopsy samples
- •In men with procreative ability: consent to the implementation of double barrier contraception method.
- •Completion of radical locoregional treatment – teleradioteraphy.
- •Completion of locoregional treatment within 3 months before inclusion to the study.
- •Giving a written informed consent.
- •ECOG performance status 0 to
- •Age over 18 years.
- •No signs of tumour cells dissemination within 28 days before inclusion to the trial, proven by radiological examinations (CT/or in case of contraindications to CT – MR of chest, abdomen and pelvis) and 68Ga-PSMA PET/CT examination.
- •Castrate testosterone level (testosterone < 50 ng/dl or 1,7 nmol/L)
- •Patients with adequate function of main organs, defined as an adequate reserve of bone marrow and function of liver and kidneys:
- •bone marrow - neutrophils > 1500x109/L; thrombocytes > 100 000x109/L; hemoglobin > 9 g/dL; 2) liver - bilirubin < 2xUNL (upper limit of normal range) and < 5xULN in patients with Gilbert's syndrome; aminotransferase < 3xUNL; 3) kidneys - eGFR > 50 ml/min; albumins > 2.5mg/ml
排除标准
- •The presence of distant metastases, proven by radiological examination or PET/CT examination with 68Ga-PSMA.
- •Absence of approval to use effective constraception method.
- •Absence of Patient's consent to participate in the study.
- •Urinary tract obstruction or/and hydronephrosis.
- •Concurrent anticancer treatment.
结局指标
主要结局
The assessment of biochemical failure ratio.
The assessment of biochemical failure ratio.
次要结局
- Biochemical Progression Free Survival - time of survival from the end of 177Lu-PSMA treatment to biochemical progression or death.
- Radiological Progression Free Survival - time of survival from the end of 177Lu-PSMA treatment to the radiological progression defined accoring to the PCWG3 criteria or death.
- Time from the end of 177Lu-PSMA treatment to inclusion of other therapeutic intervention.
- Frequency and count of Patients with adverse events.
- The comparison of quality of life ratios (EORTC QLQ-PR25) between study groups.
研究者
Centrum Wsparcia Badań Klinicznych
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
研究点 (1)
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