Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.
- Conditions
- The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT06500247
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 43
- 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;
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description experimental group Dalpicilib Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone experimental group Abiraterone Acetate (II) Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone experimental group Androgen Deprivation Therapy Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone experimental group Prednisone Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone
- Primary Outcome Measures
Name Time Method 12 Week PSA 50 12 weeks Response rate of PSA 50 at the end of 12 weeks.
- Secondary Outcome Measures
Name Time Method Radiographic Progression-Free Survival 3 years The time from randomization until the occurrence of radiographic progression or death from any cause.
Adverse event 3 years During the trial, adverse events are assessed based on laboratory and clinical examinations.
overall survival 3 years The time from the start of the study or the initiation of treatment for the patient, to the time of death from any cause.
PSA 50 3 years PSA 50 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 50% from their baseline values after treatment.
PSA 90 3 years PSA 90 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 90% from their baseline values after treatment.
Trial Locations
- Locations (1)
Qilu hospital
🇨🇳Jinan, Shandong, China