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ClinicalTrials.gov ID

NCT07503379

Lead Sponsor

Yonghong LiOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

109Estimated

Last Update Posted

Mar 31, 2026Actual

Start Date

Apr 2026Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2028Estimated

Official Title

Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study

Brief Summary

This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients.

The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.

• mHSPC

• Darolutamide + ADT Combined with Low-dose Docetaxel

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Written informed consent
2. Males ≥18 years of age
3. Histologically or cytologically confirmed adenocarcinoma of prostate
4. Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review
5. Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
6. Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before included. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks before the initiation of study is recommended. First generation anti-androgen has to be stopped prior to included.
7. An Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion Criteria:

1. Prior treatment with:

1. LHRH agonist/antagonists started more than 12 weeks before before the initiation of study
2. Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
3. Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
4. Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Yonghong LiOTHER

chennanhuiht@163.com13823880488