Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Radiographic Progression Free Survival
研究概览
简要总结
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
详细描述
Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment.
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When the patient reaches:
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PSA ≤ 0.2ng/ml
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Or PSA > 0.2ng/ml but with more that 90% decrease comparing baseline
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Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.
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When the patient:
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PSA > 0.2ng/ml and has not decreased by 90% compared to baseline
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Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria to be eligible for this study:
- •Male aged ≥18 years;
- •Histologically or cytologically confirmed prostate adenocarcinoma;
- •Metastatic disease (confirmed by conventional imaging);
- •ECOG performance status of 0-1;
- •Suitable for ADT and docetaxel treatment;
- •Good bone marrow, kidney, and liver function:
- •(1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
- •Hemoglobin (HB) ≥ 90g/L;
- •Absolute neutrophil count (ANC) ≥ 1.5×109/L;
- •Platelets (PLT) ≥ 80×109/L;
- •(2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- •Total bilirubin (TBIL) ≤ 2.0 × ULN;
- •Serum creatinine (Cr) ≤ 2.0×ULN;
- •Willing to participate in this study, sign an informed consent form, and have good compliance
排除标准
- •No metastatic disease;
- •Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer
- •Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- •Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
- •History of malignant tumors;
- •Planned receipt of other anti-tumor treatment during the study treatment period;
- •Known allergy to the above drug components;
- •Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
- •Refusal to sign the informed consent form;
- •Investigator's opinion that the participant is not suitable for inclusion.
研究组 & 干预措施
Continuous treatment group
Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC
干预措施: Darolutamide continuous (Drug)
Intermittent treatment group
Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA > 1ng/ml (or PSA > 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC.
干预措施: Darolutamide intermittent (Drug)
结局指标
主要结局
Radiographic Progression Free Survival
时间窗: 36 months
rPFS
Overall Survival
时间窗: 36 months
OS
次要结局
- Time to castration-resistant prostate cancer(36 months)
- Time to pain progression(through study completion, an average of 3 year)
研究者
Hua Lixin
M.D.
The First Affiliated Hospital with Nanjing Medical University