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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets, placebo; abiraterone acetate tablets; prednisone tablets.
- Who it may be relevant to
- Registry conditions: High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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
Interventions
- Drug dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
dalpiciclib+ abiraterone+ prednisone - Drug placebo; abiraterone acetate tablets; prednisone tablets
placebo+abirarerone+prenisone
Primary outcome measures
- Adverse event (AE) incidence [Time frame: approximately 63 months]
Secondary outcome measures (5)
- PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss) [Time frame: approximately 6 months]
- rPFS [Time frame: approximately 63 months]
- PSA response rate [Time frame: approximately 63 months]
- ORR [Time frame: approximately 63 months]
- Time to PSA progression [Time frame: approximately 63 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06099990 · SHR6390-305