NCT05778097尚未招募2 期
Adjuvant Androgen Deprivation Therapy Combined With Apalutamide for Prostate Cancer Patients Post Radical-prostatectomy With High-risk of Reoccurrence: a Prospective, Single-arm, Multicenter Trial (ARES Study)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School3 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Two-year biochemical progression-free survival
研究概览
简要总结
ARES is a multicenter, single-arm, phase 2 trial to evaluate the efficacy and safety of ADT in combination with apalutamide as an adjuvant regimen for patients with high risk of recurrence after radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;
- •Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;
- •PSA < 0.1 ng/ml within 8 weeks after surgery;
- •Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;
- •ECOG score at 0-1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale;
- •Adequate organ functions:
- •Hematology (within 14 days before treatment: no blood transfusion, no use of granulocyte colony-stimulating factor, no use of other drugs for correction)：
- •Neutrophil count (NE) ≥1.5×109/L;
- •Hemoglobin (HGB) ≥ 90 g/L;
- •Platelet count (PLT) ≥100×109/L; Coagulation function (no blood product transfusion within 14 days before treatment): international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× upper limit of normal (ULN); Blood biochemistry (liver and kidney function)：
- •Creatinine clearance ≥ 30 mL/min;
- •Total bilirubin (TBIL) ≤ 1.5× ULN;
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;
- •Ability to provide written informed consent form (ICF) and ability to understand and agree to adhere to study requirements and schedule of assessments;
- •Patients of childbearing potential must be willing to use highly effective contraception during the study and for 12 weeks after the last dose of treatment.
排除标准
- •Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;
- •Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;
- •Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;
- •Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);
- •Any major surgery (other than radical resection) requiring general anesthesia within 28 days prior to the first dose of the study;
- •Other malignancies present or occurred in the past 2 years, except cured non-melanoma skin cancers and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating of basement membrane);
- •Arterial/venous thrombotic events (such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism) or anticoagulant therapy with warfarin or heparin within 6 months before the study;
- •Corrected QT interval (QTc) of heart rate > 500 ms; patients with QTc prolonged but < 500 ms should be assessed by a cardiologist for eligibility;
- •Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; Classes III-IV cardiac insufficiency according to the New York Heart Association (NYHA) Classification, or left ventricular ejection fraction (LVEF) < 50% indicated in cardiac Doppler ultrasound;
- •Allergy to any study drug or excipients;
- •Active viral hepatitis requiring treatment as determined by the Investigators:
- •Chronic hepatitis B, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients with positive test for Hepatitis B surface antigen or core antibody);
- •Positive for Hepatitis C virus (HCV) ribonucleic acid (RNA) test (HCV RNA test only for patients with positive HCV antibodies);
- •Any present active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or long-term heavy use of hormones or other immunomodulators, or other conditions assessed by the Investigator as having an impact on study treatment;
- •Active infection;
- •History of interstitial lung disease or uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc.;
- •Known to have human immunodeficiency virus (HIV) infection;
- •History of epilepsy or conditions that may induce epilepsy
- •The presence of an underlying medical condition alcohol/drug abuse or dependence that is detrimental to the administration of the study drugs, or that may affect the interpretation of the results, or that places the patient at high risk of developing treatment complications;
- •Men who have sexual activity with women of childbearing potential, unless they:
- •Agree to use condom or spermicidal foam/gel/diaphragm/cream/suppository Agree not to donate sperm during the study and for at least 3 months after receiving the last dose of study drug No birth plan during the study or within 3 months after the last dose of study drug
- •Concurrent participation in another therapeutic clinical study.
研究组 & 干预措施
Apalutamide+ADT
Experimental
Apalutamide (240 mg once daily) in combination with ADT for 12 cycles (28 days of each cycle)
干预措施: Apalutamide 60mg Tab (Drug)
Apalutamide+ADT
Experimental
Apalutamide (240 mg once daily) in combination with ADT for 12 cycles (28 days of each cycle)
干预措施: Androgen deprivation therapy(ADT) (Drug)
结局指标
主要结局
Two-year biochemical progression-free survival
时间窗: 24 months
It is defined as the proportion of patients without biochemical progression or death 2 year after initiation with Apalutamide plus ADT. Biochemical progression is defined as an increase of more than 0.5 ng/mL from PSA nadir after treatment (confirmed rise on at least two separate occasions) or any evidence of clinical relapse/metastasis or the initiation of any anti-prostate cancer therapy or death due to any cause.
次要结局
- Event-free survival rate(from initiation with apalutamide up to 36 months)
- Biochemical progression-free survival(60 months)
- Metastasis-free survival (MFS)(60 months)
- Quality of life (QoL) assessed by FACT-P scale(24 months)
- Two-year testosterone recovery rate(24 months)
- Time to testosterone recovery(From initiation of apalutamide plus ADT up to 36 months)
- Number of Adverse Events Number of Adverse Events Number of Adverse Events Adverse events (AEs)(From initiation of apalutamide plus ADT to 30 days after last dose of apalutamide)
研究者
Hongqian Guo
Chief physician of Department of Urology
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (3)
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