Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.

Официальное название

A Prospective Exploratory Phase II Study on the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer With Darxicilib in Combination With Abiraterone Acetate (II)

Обзор

This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancer.The main questions it aims to answer are: ·PSA50 response rate at the end of week 12 Participants will: * Darxicilib: 125mg per tablet, oral administration, once daily for 21 consecutive days followed by a 7-day break. * Abiraterone Acetate tablets (II): 300mg per dose, oral administration, once daily for a 28-day cycle. * Prednisone: 5mg per tablet, oral administration, twice daily.

Подробное описание

1. This research constitutes a phase II, single-arm, multicenter exploratory study aimed at assessing the therapeutic efficacy and safety profile of the combination therapy involving Darxicilib and Abiraterone Acetate (II) in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The enrollment target is set at 43 participants who meet the eligibility criteria for the efficacy assessment phase of the trial. 2. (1)Main Research Objective To evaluate the efficacy of the treatment modality of Darxicilib in combination with Abiraterone Acetate (II) in patients with mCRPC (metastatic castration-resistant prostate cancer).

(2)Secondary Research Objectives

1. To assess the efficacy of the combination therapy in target mCRPC subjects through the time to PSA progression, PSA response rate at 12 weeks (PSA50, PSA90, and PSA ≤ 0.2 ng/ml), disease-free survival (PFS) rates at 6 and 12 months, overall survival (OS), and duration of response (DOR); 2. To evaluate the safety of the combination therapy for target mCRPC by assessing the incidence of adverse events, time to pain progression, and time to symptom progression.

(3)Exploratory Research Objective Quality of life.

Вмешательства

• Препарат Dalpicilib
  This study recruited a total of 43 subjects diagnosed with Metastatic Castration-Resistant Prostate Cancer at multiple centers from July 2024. Enrolled patients received treatment with dalpicilib until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
• Препарат Abiraterone Acetate (II)
  This study recruited a total of 43 subjects diagnosed with Metastatic Castration-Resistant Prostate Cancer at multiple centers from July 2024. Enrolled patients received treatment with Abiraterone Acetate (II) until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
• Препарат Androgen Deprivation Therapy
  This study recruited a total of 43 subjects diagnosed with mCRPC at multiple centers from July 2024. Enrolled patients received treatment with Androgen Deprivation Therapy until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
• Препарат Prednisone
  This study recruited a total of 43 subjects diagnosed with mCRPC at multiple centers from July 2024. Enrolled patients received treatment with Prednisone until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.

Первичные конечные точки

• 12 Week PSA 50 [Срок оценки: 12 weeks]

Вторичные конечные точки (5)

• Radiographic Progression-Free Survival [Срок оценки: 3 years]
• Adverse event [Срок оценки: 3 years]
• overall survival [Срок оценки: 3 years]
• PSA 50 [Срок оценки: 3 years]
• PSA 90 [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Age ≥18 years old, male;
• ECOG performance status score of 0 to 1;
• Life expectancy of at least 3 months;
• Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine or small cell carcinoma;
• Testosterone at castrate levels at screening (≤50 ng/dL or 1.73 nmol/L);
• Failure of previous treatment with new androgen receptor antagonists at the mHSPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol);
• Capable of complying with the study protocol as judged by the investigator;

Критерии исключения

• Previously received abiraterone acetate treatment for prostate cancer;
• Previously received any cytotoxic chemotherapy for mCRPC stage;
• Previously received treatment with any other cyclin-dependent kinase 4 and 6 (CDK4 \& 6) inhibitors;
• Previously received treatment with new androgen receptor antagonists at the mCRPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol);
• The washout period from the end of any previous anti-tumor treatment (including radiotherapy, surgery, molecular targeted therapy, immunotherapy, and first-generation androgen receptor antagonists) to the first administration of this study is less than 4 weeks (except for bicalutamide with a washout period less than 6 weeks);

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu hospital — Цзинань

Идентификаторы

NCT: NCT06500247 · bks04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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