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

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

NCT ID: NCT06500247

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

Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Abiraterone Acetate
Androgens

Conditions: Keywords:
Prostate Cancer
CDK4/6 inhibitor
Abiraterone

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Experimental group:Dalpicilib+Abiraterone Acetate (II) +ADT+Prednisone

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Dalpicilib
Description: 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.
Arm group label: experimental group

Intervention type: Drug
Intervention name: Abiraterone Acetate (II)
Description: 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.
Arm group label: experimental group

Intervention type: Drug
Intervention name: Androgen Deprivation Therapy
Description: 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.
Arm group label: experimental group

Intervention type: Drug
Intervention name: Prednisone
Description: 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.
Arm group label: experimental group

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.

Criteria for 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);

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Qilu hospital

Address:
City: Jinan
Zip: 250012
Country: China

Contact:
Last name: Benkang Shi, doctor

Phone: 18560083917
Email: bkang68@sdu.edu.cn

Start date: July 31, 2024

Completion date: March 31, 2027

Lead sponsor:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Collaborator:
Agency: Jiangsu HengRui Medicine Co., Ltd.
Agency class: Industry

Source: Qilu Hospital of Shandong University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06500247