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安斯泰来研究编号
5541-CL-0201

一项评估 ASP5541 对前列腺癌参与者的疗效的 2 期研究

安斯泰来研究编号
5541-CL-0201
Clinicaltrials.gov 登记号
NCT07005154
EUCTIS 编号
2024-517653-27
jRCT ID
N/A
中国 CDE 登记号
N/A
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试验目的

激素疗法，又称雄激素剥夺治疗（ADT），是治疗前列腺癌的标准方法。其作用机制是降低体内主要男性性激素睾酮的含量。雄激素受体通路抑制剂（ARPI）是另一种激素疗法。它们要么减慢睾酮的生成量，要么阻止睾酮到达前列腺癌细胞。醋酸阿比特龙（AA）是一种 ARPI，用于治疗晚期前列腺癌。此类治疗通常以片剂形式给药，并与一种名为泼尼松/泼尼松龙的类固醇合用，用于控制激素治疗可能引发的任何健康问题。

ASP5541 是一种不同形式的 AA。它通过肌肉注射给药。在这项研究中，晚期前列腺癌男性参与者将接受 ASP5541 联合和不联合泼尼松/泼尼松龙治疗。本研究将评估 ASP5541 的安全性，并比较 ASP5541 与 AA 在晚期前列腺癌男性患者中的疗效。

更多研究详情

研究分期
2 期
研究产品
ASP5541
泼尼松
泼尼松龙
醋酸阿比特龙
研究产品
PRL-02
研究类型
干预性
盲法
None (Open Label)
入组人数
218
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谁可以参加

患有特定类型晚期前列腺癌的成年男性可以参与研究。他们的癌症已扩散到身体的其他部位（转移性）。不同类型包括：

  • 转移性激素敏感性前列腺癌（mHSPC）。依赖睾酮生长的前列腺癌。
  • 转移性去势抵抗性前列腺癌（mCRPC）。即使在睾酮水平较低时仍持续进展的前列腺癌。

预期结果

在本研究中，将有 3 个治疗组：

  • 在第 1 组中，既往未接受过 ARPI 治疗的 mCRPC 男性患者将接受 ASP5541 联合泼尼松/泼尼松龙或 AA 联合泼尼松/泼尼松龙治疗。
  • 在第 2 组中，既往未接受过 ARPI 治疗的 mHSPC 男性患者将接受 ASP5541 单药治疗或 AA 联合泼尼松/泼尼松龙治疗。
  • 在第 3 组中，可能既往接受过或未接受过 ARPI 治疗的日本 mCRPC 或 mHSPC 男性患者将接受 ASP5541 联合泼尼松治疗。

ASP5541 将每 12 周一次通过肌肉注射给药。mCRPC 男性参与者将每天服用两次泼尼松/泼尼松龙， mHSPC 男性参与者将每天服用一次泼尼松/泼尼松龙。AA 将以片剂形式给药，每天服用一次。所有组还将接受标准治疗，如 ADT。

男性参与者将在治疗期间及治疗结束后定期前往诊所进行健康检查，包括排查任何健康问题。在一些就诊中，他们还将接受扫描，以检查癌症是否有任何变化。访视次数和每次访视时进行的安全检查类型将取决于每名受试者的健康状况以及他们完成治疗的时间。

Timer icon
研究治疗持续时间
约 40 个月
Coin icon
研究访问次数
约 20

试验摘要

本试验的主要目的（首要目的）为：

  • 对比 AA 联合泼尼松/泼尼松龙，评估 ASP5541 联合泼尼松/泼尼松龙在既往未接受过 ARPI 治疗的晚期前列腺癌男性患者中的疗效。
  • 评估 ASP5541 单独给药在既往未接受过 ARPI 治疗的晚期前列腺癌男性患者中的安全性。
  • 对比 AA 联合泼尼松/泼尼松龙，评估 ASP5541 单独给药在既往未接受过 ARPI 治疗的晚期前列腺癌男性患者中的疗效。
  • 评估 ASP5541 联合泼尼松/泼尼松龙在日本晚期前列腺癌男性患者中的安全性

本试验的其他目的（次要目的）为：

  • 对比 AA 联合泼尼松/泼尼松龙，进一步评估 ASP5541 联合和不联合泼尼松/泼尼松龙的疗效。
  • 对比 AA 联合泼尼松/泼尼松龙，评估 ASP5541 联合和不联合泼尼松/泼尼松龙的安全性
  • 对比 AA 联合泼尼松/泼尼松龙，评估 ASP5541 联合和不联合泼尼松/泼尼松龙对身体的影响（药效学）
  • 对比 AA 联合泼尼松/泼尼松龙，评估 ASP5541 联合和不联合泼尼松/泼尼松龙治疗后的疼痛水平

地点

未找到任何位置。

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    试验信息
    关注试验
    参与者年龄
    18 岁及以上
    疾病
  • 前列腺癌
    • 参与者性别
    男性
    试验开展时间
    2025年6月 - 2032年5月
    更多研究详情
    入选标准
    • 参与者经组织学或细胞学检验被确诊为无神经内分泌分化或小细胞特征的前列腺腺癌。
    • 试验参与者的美国东部肿瘤学协作组（ECOG）体能状态评分为 0 或 1，若因骨痛引起，ECOG 体能状态评分为 2。
    • Participant with mHSPC must have an estimated life expectancy of ≥ 12 months or > 6 months if participant has mCRPC.
    • Participant is able to understand and comply with all study requirements and procedures, including completion of PRO questionnaires.
    • Male participant must agree to use defined forms of contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration.
    • Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration.
    • Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration.
    • 参与者臀肌腹侧肌群的肌肉量充足，适合进行肌肉注射。
    • 参与者同意在本研究中接受 ASP5541 治疗期间不参加另一项干预性研究。
    • 试验参与者在筛查时，血清钾水平应在正常范围内（符合当地实验室的正常参考范围），且未进行补充。Inclusion Criteria for Cohort 1
    • Participant has been diagnosed with mCRPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).
    • Participant has evidence of disease progression defined as at least 1 of the following criteria at study entry.
      • Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment defined as PD on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3.
      • PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng/mL above the nadir, confirmed by a second value at least 1 wk later, and with at least 1 of the measurements within 90 days prior to screening. PSA 谷值定义为最近一次治疗期间或之后测得的最低 PSA 值。
    • 试验参与者正在接受促性腺激素释放激素（GnRH）类似物进行的持续雄激素剥夺治疗，或有双侧睾丸切除术史（即外科或药物去势）。NOTE: Participants who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.
    • Participant has a serum testosterone level < 1.73 nmol/L (< 50 ng/dL) at Screening visit.
    • Participant is able to swallow AA.

      • Inclusion Criteria for Cohort 2

    • Participant has been diagnosed with mHSPC documented by metastatic lesions on a bone scan, CT, MRI or PSMA-PET.
    • Participant must have started castration therapy (i.e., medical or surgical) at least 14 days prior to Cycle 1 Day 1. NOTE: A participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.
    • Participant should have a baseline morning serum cortisol of ≥ 14 mcg/dL.
    • Participant is able to swallow AA.
    • For Groups B and C, participant has accessible archival tumor tissue from the primary tumor (preferred) or metastatic site (excluding bone) for which source and availability have been confirmed prior to study treatment.
    排除标准
    • Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.
    • 参与者发生已知活动性中枢神经系统（CNS）转移。NOTE: a participant with CNS metastases that have been treated with surgery and/or radiation therapy, who is no longer taking pharmacologic doses of glucocorticoids and is neurologically stable, is eligible.
    • Participant has a known additional malignancy beyond prostate cancer that requires active treatment, with the exception of any of the following:
      • Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of any type
      • Adequately treated Stage I cancer from which participant is currently in remission and has been in remission for ≥ 2 years
      • Any other cancer from which participant has been disease-free for ≥ 5 years
    • Participant has any unresolved National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v5.0) Grade > 2 toxicity at the Screening visit. NOTE: A participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.
    • 参与者在筛查前 90 天内曾接受过重大手术（例如需要全身麻醉的手术），或尚未从手术中完全恢复，或在预计参与研究期间计划接受重大手术。
    • Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to Cycle 1 Day 1.
    • Participant received a blood transfusion within 1 month of Cycle 1 Day 1.
    • 试验参与者有垂体或肾上腺功能障碍病史（例如艾迪生病、库欣综合征）。
    • Participant has hemoglobin A1c (HbA1c) > 10% and was previously diagnosed with diabetes mellitus. Participant has HbA1c > 8% and was not previously diagnosed with diabetes mellitus (excluded participants may be rescreened after referral and evidence of improved control of their condition).
    • Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M (IgM) positive, but testing for hepatitis A in screening is not required), hepatitis B [hepatitis B surface antigen (HBsAg) positive, or hepatitis B virus (HBV) DNA positive if HBsAg negative/anti-HBc positive]), or hepatitis C virus (HCV) antibody positive, confirmed by HCV RNA).
    • 参与者存在中度或重度肝功能损害（Child-Pugh 分级 B 级或 C 级）。
    • 已知有人免疫缺陷病毒（HIV）感染史的受试者。除非当地卫生当局强制要求，否则无需进行 HIV 检测。
    • 参与者的身体体重指数大于 40 kg/m2。
    • Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria within 2 yrs before screening.
    • Participant has received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 wks prior to Cycle 1 Day 1. 允许使用外用、眼内、吸入、鼻内或关节内糖皮质激素。
    • Participant received treatment with herbal medications within 4 wks prior to Cycle 1 Day 1 (e.g., saw palmetto). 试验参与者必须同意在参加研究期间不使用草药产品。
    • Participant is receiving current treatment with systemic ketoconazole or any other cytochrome 450 (CYP17) inhibitor. Participants who have received systemic ketoconazole or any other CYP17 inhibitor must have discontinued these agents ≥ 4 wks prior to Cycle 1 Day 1.
    • Participant is receiving CYP2D6 substrates with a narrow therapeutic index (applies to Cohorts 1 & 2 only).
    • Participant received prior systemic treatment with a strong inducer or inhibitor of CYP3A4 within 4 weeks of Cycle 1 Day 1. 研究期间禁止同时使用 CYP3A4 强诱导剂或强抑制剂。
    • Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg. NOTE: Participants who switch from a high dose to a dose of 30 µg/day or less prior to Cycle 1 Day 1 are eligible for study entry.
    • Participant has received a live, attenuated vaccine within 30 days of planned start of study therapy. Examples of live, attenuated vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette Guérin and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live, attenuated vaccines and are not allowed.
    • Participant is required to use any prohibited medication per List of Excluded Concomitant Medications.
    • Participant has received any investigational therapy within 4 weeks (wks0 or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
    • Participant has received ASP5541 (PRL-02) previously.
    • Participant has absolute neutrophil count < 1500/μL, platelet count < 100,000/μL, hemoglobin < 9 g/dL (6.2 mmol/L ) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants, in which case INR ≤ 2.0 is permitted) at Screening. NOTE: A participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.
    • Participant has serum total bilirubin (TBL) > 1.5 x upper limit of normal (ULN) (except participants with documented Gilbert’s disease) or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN at Screening.
    • Participant does not have adequate renal function defined as a calculated creatinine clearance < 30 mL/min as determined by a validated algorithm for calculating creatinine clearance at Screening.
    • 参与者在筛查时血清白蛋白水平低于 3.0 g/dL（30 g/L）。
    • Participant has a known or suspected hypersensitivity to ASP5541, AA (Cohorts 1 and 2 only), prednisone or any components of the formulations used in the study.
    • Participant has a gastrointestinal (GI) disorder affecting absorption.

      • Exclusion Criteria for Cohort 1

    • Prior treatment with a second-generation ARPI (e.g., AA, enzalutamide, apalutamide or darolutamide). NOTE: limited treatment with a second-generation ARPI in the neo-adjuvant, adjuvant or non-metastatic biochemically recurrent setting is permitted as long as there was no evidence of disease progression for at least 6 months following last dose.
    • Treatment with any of the following for prostate cancer, during the indicated timeframe prior to enrollment:
      • Hormonal therapy (e.g., AR antagonists, 5 alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 wks of Cycle 1 Day 1. Note: Treatment with bicalutamide within 6 wks prior to enrollment is not permitted. Treatment with GnRH agonists or antagonists is permitted.
      • Chemotherapy within 2 wks or 5 half-lives of Cycle 1 Day 1 (whichever is longer)
      • Biologic therapy within 4 wks of Cycle 1 Day 1
      • Immunotherapy within 4 wks of Cycle 1 Day 1
      • Radiation therapy (includes radioligands) within 4 wks of Cycle 1 Day 1
    • Participant with a known BRCA mutation should be excluded unless they have previously received a PARPi or are not eligible for a PARPi, or a PARPi is not available.
    • 参与者存在具有临床意义的心脏疾病，定义为符合以下任一情况：
      • Clinically significant cardiac arrhythmias including bradyarrhythmia, which are poorly controlled. 允许心率可控的心房颤动。
      • 先天性长 QT 综合征。
      • QTcF ≥ 450 msec at Screening. If the QTc is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.
      • History of clinically significant cardiac disease or congestive heart failure greater than NYHA Class II or left ventricular ejection fraction measurement of < 50% at baseline. Participants must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
      • Uncontrolled hypertension, defined as systolic BP > 160 mmHg or diastolic BP> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.
      • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring > 1 month before Cycle 1 Day 1).

      • Exclusion Criteria for Cohort 2

    • Prior treatment with a second-generation ARPI (e.g., AA, enzalutamide, apalutamide or darolutamide). Note: limited treatment with a second-generation ARPI in the neo-adjuvant, adjuvant or non-metastatic biochemically recurrent setting is permitted as long as there was no evidence of disease progression for at least 6 months following last dose.
    • Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer. The following exceptions are permitted:
      • Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 4 months prior to Cycle 1 Day 1) with or without concurrent antiandrogens, with no radiographic evidence of disease progression or rising PSA levels prior to Cycle 1 Day 1.
      • Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 wks prior to Cycle 1 Day 1. Radiotherapy to the prostate for participants with low volume metastatic disease is also permitted if it was administered at least 4 wks prior to Cycle 1 Day 1.
      • Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to Cycle 1 Day 1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to Cycle 1 Day 1.
      • Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to Cycle 1 Day 1 if participant was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to Cycle 1 Day 1.
    • 参与者存在具有临床意义的心脏疾病，定义为符合以下任一情况：
      • Clinically significant cardiac arrhythmias including bradyarrhythmia, which are poorly controlled. 允许心率可控的心房颤动。
      • 先天性长 QT 综合征。
      • QTcF ≥ 450 msec at Screening. If the QTc is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.
      • History of clinically significant cardiac disease or congestive heart failure greater than NYHA Class II or left ventricular ejection fraction measurement of < 50% at baseline. Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.
      • Uncontrolled hypertension, defined as systolic BP > 140 mmHg or diastolic BP > 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. 试验参与者最多可接受 2 种抗高血压药治疗，这些药物在第 1 周期第 1 天前至少 3 个月开始使用。
    • Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.
      • Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring > 1 month before Cycle 1 Day 1).

    常见问题

    临床试验是否只针对晚期癌症患者？

    虽然某些临床试验可能侧重于更晚期的癌症，但许多试验对处于不同癌症阶段的患者开放。每项研究都有关于参与资格的规定。例如，只有特定年龄段的患者或患有特定类型肿瘤的患者才能参与。

    我是否需要停止当前治疗才能参加临床试验？

    有时，研究人员希望参与者在临床试验期间继续接受当前治疗。有时，您可能需要暂停当前的治疗。如果研究性治疗无效，您通常可以恢复原有的治疗方案。

    我是否应该担心会服用安慰剂？

    在癌症临床试验中，只有当该类癌症尚无其他治疗方法时，才会使用安慰剂。这有助于将研究性治疗与安慰剂进行比较。安慰剂在癌症试验中很少使用，因为通常会采用最佳可用疗法，即所谓的“标准治疗方案”。

    我是否需要医生转诊才能参加一项研究？

    您的医生可能并不了解所有可供您参与的临床试验机会。请与您的医生或其他医疗服务提供者讨论您所找到的临床试验信息。他们可以帮助您判断临床试验是否适合您。若您在本网站未找到任何选择，建议访问临床试验注册网站（如 clinicaltrials.gov），以查看各类可参与的临床试验。

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