Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06099990
Start Date
October 1 2023
End Date
December 1 2028
Last Update
October 25 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.