2022-502244-12-00招募中3 期
(21140 ARANOTE) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).
Bayer Consumer Care AG, Bayer AG16 个研究点 分布在 3 个国家目标入组 132 人开始时间: 2023年5月20日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 16
- 主要终点
- Radiological progression-free survival
研究概览
简要总结
To determine if darolutamide in addition to ADT is superior to placebo plus ADT by improving rPFS in participants with mHSPC.
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
- •Written informed consent obtained. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Sexually active male participants must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with study drug/placebo and for 4 weeks after treatment with study drug/placebo.
- •Males ≥18 years of age.
- •Histologically or cytologically confirmed adenocarcinoma of prostate.
- •Documented metastatic disease by conventional imaging method either by a positive 99mTc-phosphonate bone scan, or soft tissue or visceral metastases, either by contrastenhanced abdominal/pelvic/chest CT or MRI scan assessed by central review. Note: Metastatic disease is defined as either malignant lesions in bone scan or measurable lymph nodes above the aortic bifurcation or soft tissue/visceral lesions according to RECIST version 1.
- •Lymph nodes are measurable if the short axis diameter is ≥15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is ≥10 mm. Regional lymph node metastases only (N1, below the aortic bifurcation) will not be considered as metastases eligible for the study. Only participants with non-regional lymph node metastases (M1a) and/or bone metastases (M1b) and/or other sites of metastases with or without bone disease (M1c), assessed according to National Comprehensive Cancer Network (NCCN) classification, will be eligible.
- •Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti–androgen, but no longer than 12 weeks before randomization. For participants receiving LHRH agonists, treatment in combination with a first generation anti–androgen for at least 14 days prior to randomization is recommended.
- •First generation anti–androgen must be discontinued at least 1 day before study treatment start.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or
- •Blood counts at Screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5x10^9/L, platelet count ≥100x10^9/L (participant must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at Screening).
- •Screening values of serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤1.5 x ULN, total bilirubin ≤1.5 x ULN, creatinine ≤2.0 x ULN.
排除标准
- •Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- •Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management.
- •A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug.
- •Previous (within 28 days before the start of study drug or 5 half–lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
- •Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his/her compliance with study procedures or may interfere with the participant’s participation in the study or evaluation of the study results.
- •Inability to swallow oral medications.
- •Known brain/ leptomeningeal metastases Note: Brain CT/MRI scan should be performed only in case of symptoms.
- •"Prior treatment with: - LHRH agonist/antagonists started >12 weeks before randomization starts except neoadjuvant and /or adjuvant therapy for a duration ≤ 24 months and completed ≥ 12 months prior to randomization - Second–generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors - Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer - Chemotherapy including docetaxel or immunotherapy for prostate cancer - Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization - radiopharmaceuticals - Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT"
- •Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy) within 2 weeks before randomization.
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
- •Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s).
- •Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization.
- •An active viral hepatitis (defined as Hepatitis B surface antigen [HBsAg] reactive or detectable [qualitative] hepatitis B virus [HBV] DNA or defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected), known human immunodeficiency virus (HIV) infection with detectable viral load, or chronic liver disease with a need of treatment. Note: No testing for Hepatitis B and/or Hepatitis C is required unless mandated by local authority. No HIV testing is required unless mandated by local authority.
- •Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV).
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Radiological progression-free survival
Radiological progression-free survival
次要结局
- Time to pain progression
- Overall survival (OS)
- Time to castration–resistant prostate cancer (CRPC)
- Time to initiation of subsequent anti-cancer therapy
- Time to PSA progression
- Percentage of participants with detectable PSA values (≥0.2 ng/mL) at baseline which become undetectable (<0.2 ng/mL)
- Number of participants with treatment emergent adverse events
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (16)
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