一项评估 ASP5541 对前列腺癌参与者的疗效的 2 期研究Trial ID 5541-CL-0201

试验目的

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitor inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone/prednisolone to manage any medical problems from the hormone therapy.

ASP5541 is a different form of AA. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone/prednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to AA.

谁可以参加

Adult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:

Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.
Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.

预期结果

In this study there will be 3 treatment groups:

In Group 1, men with mCRPC who haven’t previously been treated with an ARPI will either be given ASP5541 and prednisone/prednisolone or AA and prednisone/prednisolone.
In Group 2, men with mHSPC who haven’t previously been treated with an ARPI will either be given ASP5541 by itself or be given AA with prednisone/prednisolone.
In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an ARPI will be given ASP5541 with prednisone.

ASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone/prednisolone twice daily and men with mHSPC will take prednisone/prednisolone once daily. AA will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as ADT.

The men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. 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。The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.

研究治疗持续时间

Approximately 40 months

研究访问次数

Approximately 20

试验摘要

The main aims (primary objectives) of this trial are:

To check how well ASP5541 with prednisone/prednisolone works compared to AA with prednisone/prednisolone in men with advanced prostate cancer who haven’t previously been treated with an ARPI.
To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven’t previously been treated with an ARPI.
To check how well ASP5541 given by itself works compared to AA with prednisone/prednisolone in men with advanced prostate cancer that haven’t previously been treated with an ARPI.
To check the safety of ASP5541 with prednisone/prednisolone in Japanese men with advanced prostate cancer

Other aims (secondary objectives) of this trial are:

Further checks on how well ASP5541 works with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone.
To check the safety of ASP5541 given with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone
To check how ASP5541 given with and without prednisone/ prednisolone acts upon the body (pharmacodynamics) compared to AA given with prednisone/prednisolone
To check the pain levels after treatment with ASP5541 given with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone

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

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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。
Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.
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。
Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.

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。
Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). 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.
Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
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). Participants must agree not to use herbal products during study participation.
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. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.
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。If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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一项评估 ASP5541 对前列腺癌参与者的疗效的 2 期研究