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NCT Number: NCT06099990

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)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets

Drug

dalpiciclib+ abiraterone+ prednisone

placebo; abiraterone acetate tablets; prednisone tablets

Drug

placebo+abirarerone+prenisone

Primary outcomes

  1. Adverse event (AE) incidence

    Time frame: approximately 63 months

Secondary outcomes

  1. PK: Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)

    Time frame: approximately 6 months

  2. rPFS

    Time frame: approximately 63 months

    Time from randomisation to radiologically confirmed progressive disease or death due to any cause

  3. PSA response rate

    Time frame: 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

    Time frame: 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

    Time frame: approximately 63 months

    Time from randomisation to the first time of PSA progression

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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).

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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