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Trial Title:
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)
NCT ID:
NCT06099990
Condition:
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Prednisone
Abiraterone Acetate
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
Description:
dalpiciclib+ abiraterone+ prednisone
Arm group label:
dalpiciclib+ abiraterone+ prednisone
Intervention type:
Drug
Intervention name:
placebo; abiraterone acetate tablets; prednisone tablets
Description:
placebo+abirarerone+prenisone
Arm group label:
placebo+abirarerone+prenisone
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age of ≥ 18 years old,male
2. ECOG PS score of 0 or 1；
3. Prostate adenocarcinoma confirmed by histological。
4. ADT no more than 3 months prior to randomization (when docetaxel is not used) with
no radiographic or PSA progression
5. 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)
6. Voluntarily participate in this clinical trial, understand the study procedure and
have signed informed consent
Exclusion Criteria:
1. Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy,
radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency
ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
2. 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
3. Confirmed by imaging, there are brain tumor foci
4. History of severe lung disease such as interstitial pneumonia
5. Plan to receive any other antitumor therapy during this trial
6. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors
that affect drug taking and absorption
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099990
