> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dalpiciclib-isethionate-tablets-combined-with-abiraterone-7414de80-9a4d-4c54-8156-1182a1db41fa > Record changed: 2026-10-13 # 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) NCT06099990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) Participants 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) Start date 2023-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Short 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **First posted** 2023-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Registry last updated** 2023-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Start date** 2023-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Size and sites **Participants** 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Planned participants** 660 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Identifiers **Registry ID** NCT06099990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **ClinicalTrials.gov ID** NCT06099990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Outcomes ### Primary outcomes 1. Adverse event (AE) incidence Timeframe: approximately 63 months ### Secondary outcomes 1. PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss) Timeframe: approximately 6 months 2. rPFS Timeframe: approximately 63 months Time from randomisation to radiologically confirmed progressive disease or death due to any cause 3. PSA response rate Timeframe: 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 4. ORR Timeframe: 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 5. Time to PSA progression Timeframe: approximately 63 months Time from randomisation to the first time of PSA progression Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06099990) ## Related records ### Drugs (3) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Dalpiciclib](https://trialight.com/data/asset/dalpiciclib-2001da9e-4c75-4a18-ae80-97f8c567dba5.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (1) - [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) Primary condition ### Targets (2) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) --- ## A note for AI agents You are probably reading this for a person. 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