The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate CancerPhase 2NCT06500247

Darxicilib Combined With Abiraterone Acetate Tablets (II) for the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer.

A Phase 2 study testing Dalpicilib, Abiraterone Acetate (II) and Androgen Deprivation Therapy in people with The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer, run by Qilu Hospital of Shandong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study is a single-arm, multicenter, phase II exploratory trial. The purpose is to explore the efficacy and safety of Darxicilib in combination with Abiraterone Acetate for the treatment of subjects with metastatic castration-resistant prostate cancer.The main questions it aims to answer are: ·PSA50 response rate… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
What is being tested?: Dalpicilib, Abiraterone Acetate (II) and Androgen Deprivation Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteChina
Study dates: 31 Jul 2024to 31 Mar 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years old, male;
ECOG performance status score of 0 to 1;
Life expectancy of at least 3 months;
Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine or small cell carcinoma;
Testosterone at castrate levels at screening (≤50 ng/dL or 1.73 nmol/L);
Failure of previous treatment with new androgen receptor antagonists at the mHSPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol);
Capable of complying with the study protocol as judged by the investigator;

Who cannot join

Previously received abiraterone acetate treatment for prostate cancer;
Previously received any cytotoxic chemotherapy for mCRPC stage;
Previously received treatment with any other cyclin-dependent kinase 4 and 6 (CDK4 \& 6) inhibitors;
Previously received treatment with new androgen receptor antagonists at the mCRPC stage (such as enzalutamide, apalutamide, ODM-201, SHR3680, HC-1119, and pucrol);
The washout period from the end of any previous anti-tumor treatment (including radiotherapy, surgery, molecular targeted therapy, immunotherapy, and first-generation androgen receptor antagonists) to the first administration of this study is less than 4 weeks (except for bicalutamide with a washout period less than 6 weeks);

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Qilu hospital
Jinan, Shandong, 250012
Benkang Shi, doctor, 18560083917, bkang68@sdu.edu.cn

Other trials in China

About this study

Official title: A Prospective Exploratory Phase II Study on the Treatment of Advanced Metastatic Castration-resistant Prostate Cancer With Darxicilib in Combination With Abiraterone Acetate (II)

·PSA50 response rate at the end of week 12

Participants will:

Darxicilib: 125mg per tablet, oral administration, once daily for 21 consecutive days followed by a 7-day break.
Abiraterone Acetate tablets (II): 300mg per dose, oral administration, once daily for a 28-day cycle.
Prednisone: 5mg per tablet, oral administration, twice daily.

Read the detailed description

This research constitutes a phase II, single-arm, multicenter exploratory study aimed at assessing the therapeutic efficacy and safety profile of the combination therapy involving Darxicilib and Abiraterone Acetate (II) in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The enrollment target is set at 43 participants who meet the eligibility criteria for the efficacy assessment phase of the trial.
(1)Main Research Objective To evaluate the efficacy of the treatment modality of Darxicilib in combination with Abiraterone Acetate (II) in patients with mCRPC (metastatic castration-resistant prostate cancer). (2)Secondary Research Objectives
To assess the efficacy of the combination therapy in target mCRPC subjects through the time to PSA progression, PSA response rate at 12 weeks (PSA50, PSA90, and PSA ≤ 0.2 ng/ml), disease-free survival (PFS) rates at 6 and 12 months, overall survival (OS), and duration of response (DOR);
To evaluate the safety of the combination therapy for target mCRPC by assessing the incidence of adverse events, time to pain progression, and time to symptom progression. (3)Exploratory Research Objective Quality of life.

Conditions: The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Being tested: Dalpicilib, Abiraterone Acetate (II), Androgen Deprivation Therapy, Prednisone
Keywords: Prostate Cancer, CDK4/6 inhibitor, Abiraterone
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DalpicilibDrug
This study recruited a total of 43 subjects diagnosed with Metastatic Castration-Resistant Prostate Cancer at multiple centers from July 2024. Enrolled patients received treatment with dalpicilib until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
Abiraterone Acetate (II)Drug
This study recruited a total of 43 subjects diagnosed with Metastatic Castration-Resistant Prostate Cancer at multiple centers from July 2024. Enrolled patients received treatment with Abiraterone Acetate (II) until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
Androgen Deprivation TherapyDrug
This study recruited a total of 43 subjects diagnosed with mCRPC at multiple centers from July 2024. Enrolled patients received treatment with Androgen Deprivation Therapy until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.
PrednisoneDrug
This study recruited a total of 43 subjects diagnosed with mCRPC at multiple centers from July 2024. Enrolled patients received treatment with Prednisone until disease progression or intolerable toxicity, with a maximum treatment duration of up to 2 years. Follow-up visits were conducted monthly after patient enrollment. The last follow-up was completed in March 2027.

Study groups in NCT06500247
Study group	Role	What they receive
experimental group	Experimental	Androgen Deprivation Therapy+Darxicilib+Abiraterone Acetate（II）+Prednisone Receives: Drug: Dalpicilib; Drug: Abiraterone Acetate (II); Drug: Androgen Deprivation Therapy; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

12 Week PSA 50
Response rate of PSA 50 at the end of 12 weeks.
Measured: 12 weeks

Secondary outcomes (5)

Radiographic Progression-Free Survival
The time from randomization until the occurrence of radiographic progression or death from any cause.
Measured: 3 years
Adverse event
During the trial, adverse events are assessed based on laboratory and clinical examinations.
Measured: 3 years
overall survival
The time from the start of the study or the initiation of treatment for the patient, to the time of death from any cause.
Measured: 3 years
PSA 50
PSA 50 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 50% from their baseline values after treatment.
Measured: 3 years
PSA 90
PSA 90 is defined as the percentage of patients experiencing a reduction in prostate-specific antigen (PSA) levels by at least 90% from their baseline values after treatment.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202431 Mar 2027

First posted15 Jul 2024
Study start31 Jul 2024 (estimated)
Primary completion31 Mar 2027 (estimated)
Study completion31 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for The Efficacy of Abiraterone Acetate Combined With Dalpicilib in the Treatment of Patients With Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Experimental group:Dalpicilib+Abiraterone Acetate (II) +ADT+Prednisone
Masking: None (open label)
Enrolment: 43 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06500247
Sponsor's protocol ID: bks04
Status last verified: Jun 2024
First submitted: 27 Jun 2024
Last updated: 15 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No