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

NCT06500247 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Phase 2

Started

2024-07-31

Last updated

2024-07-15

Condition(s) studied

The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

Dalpicilib →Abiraterone Acetate (II) →Androgen Deprivation TherapyPrednisone →

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.

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.

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.

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.

Study 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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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);

Primary outcome measure(s)

12 Week PSA 50 — 12 weeks
Response rate of PSA 50 at the end of 12 weeks.

Trial sites (1)

Facility	City	Region	Status
Qilu hospital	Jinan	Shandong

On this site

📄 Deltasone (prednisone) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06500247 on ClinicalTrials.gov ↗ ← All trials in China