Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC
ConditionmHSPC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorYonghong Li
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Darolutamide + ADT Combined with Low-dose Docetaxel
Treatment groups
No treatment groups listed
Sponsors and collaborators
Yonghong Li
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov