Darolutamide with ADT and Low-Dose Docetaxel in Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multicenter phase 2 study evaluating the safety and potential efficacy of combining darolutamide with ADT and low-dose docetaxel in men with metastatic hormone-sensitive prostate cancer. The primary goal is to see what proportion of participants achieve a PSA level below 0.2 ng/mL at 24 weeks. The trial plans to enroll about 109 patients and compares outcomes to expectations from prior studies, aiming to preserve PSA responses while reducing chemotherapy exposure. Participants must have documented metastatic disease, be suitable for ADT and docetaxel, and maintain a good performance status. This study is conducted at select centers in China, led by Yonghong Li.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Affiliated Cancer Hospital of Guangzhou Medical University
  Guangzhou, China Not yet recruiting
• Meizhou People's Hospital
  Meizhou, China Not yet recruiting

Study contacts

• Study coordinator: yonghong Li
• Email: liyongh@sysucc.org.cn
• Phone: 13711376697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.