NCT06099990

Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment

Conditions

• High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Interventions

Type	Name	Description
DRUG	dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets	dalpiciclib+ abiraterone+ prednisone
DRUG	placebo; abiraterone acetate tablets; prednisone tablets	placebo+abirarerone+prenisone

Timeline

• Start date: 2023-10-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-10-25
• Last updated: 2023-10-25