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)
- Conditions
- High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
- Interventions
- Registration Number
- NCT06099990
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 660
- Age of ≥ 18 years old,male
- ECOG PS score of 0 or 1；
- Prostate adenocarcinoma confirmed by histological。
- ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
- Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)
- Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent
- Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
- Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy
- Confirmed by imaging, there are brain tumor foci
- History of severe lung disease such as interstitial pneumonia
- Plan to receive any other antitumor therapy during this trial
- Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo+abirarerone+prenisone placebo; abiraterone acetate tablets; prednisone tablets - dalpiciclib+ abiraterone+ prednisone dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets -
- Primary Outcome Measures
Name Time Method Adverse event (AE) incidence approximately 63 months
- Secondary Outcome Measures
Name Time Method PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss) approximately 6 months PSA response rate approximately 63 months In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
rPFS approximately 63 months Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time to PSA progression approximately 63 months Time from randomisation to the first time of PSA progression
ORR approximately 63 months Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses