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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for men with advanced metastatic castration-resistant prostate cancer, a type of prostate cancer that no longer responds to hormone therapy. The trial will investigate the effectiveness and safety of two medications: Darxicilib and Abiraterone Acetate. The main goal is to see how many participants achieve a significant drop in their prostate-specific antigen (PSA) levels after 12 weeks of treatment.

To be eligible for this trial, participants must be men aged 18 or older with a confirmed diagnosis of prostate cancer that has spread and is resistant to standard hormone treatments. They should also have a good performance status, meaning they are relatively healthy and can carry out daily activities. Participants will take Darxicilib and Abiraterone Acetate as tablets daily for a set period, along with another medication called Prednisone. It's important to note that this trial is not yet recruiting participants, but it aims to provide new insights into treatment options for this challenging condition.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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;
• Exclusion Criteria:
• • 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);