Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC
Starting soon · Phase 2
Conditions studied: mHSPC
In brief
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.
Key facts
- Study ID
- NCT07503379
- Run by
- Yonghong Li
- People needed
- 109
- Starts
- 2026-04-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent
- Males ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of prostate
- 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
- Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
- 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.
- An Eastern Cooperative Oncology Group performance status of 0 or 1
You may not qualify if…
- Prior treatment with:
- LHRH agonist/antagonists started more than 12 weeks before before the initiation of study
- Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
- Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
- 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
Where it is running
- Affiliated Cancer Hospital of Guangzhou Medical University — Guangzhou, China
- Meizhou People's Hospital — Meizhou, China
Full record on ClinicalTrials.gov
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