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

NCT06500247 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: bks04
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prostate Cancer; CDK4/6 inhibitor; Abiraterone

Outcome Measures

Primary Outcomes (1)

• 12 Week PSA 50

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

  12 weeks

Secondary Outcomes (5)

• Radiographic Progression-Free Survival

  3 years

• Adverse event

  3 years

• overall survival

  3 years

• PSA 50

  3 years

• PSA 90

  3 years

Study Arms (1)

experimental group

EXPERIMENTAL

Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone

Drug: Dalpicilib; Drug: Abiraterone Acetate (II); Drug: Androgen Deprivation Therapy; Drug: Prednisone

Interventions

Dalpicilib DRUG

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.

experimental group

Abiraterone Acetate (II) DRUG

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.

experimental group

Androgen Deprivation Therapy DRUG

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.

experimental group

Prednisone DRUG

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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Androgen Antagonists; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group:Dalpicilib+Abiraterone Acetate (II) +ADT+Prednisone

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 15, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)