Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
An Open-Label, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 in Combination With Endocrine Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Sponsor: Shanghai Changzheng Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Adverse Events (AEs)
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Secondary Endpoints
PSA Undetectable Rate
PSA Response Rate
Time to CRPC（Castration-Resistant Prostate Cancer）
Eligibility Criteria
Inclusion Criteria: 1. Male, aged ≥ 18 years. 2. Histologically or cytologically confirmed newly diagnosed metastatic hormone-sensitive prostate adenocarcinoma, without small cell carcinoma or small cell components. 3. Presence of at least one bone metastasis or visceral metastasis (excluding lymph nodes) detected by systemic imaging (CT/MRI). 4. No prior treatment for prostate cancer before enrollment (including but not limited to radical surgery, radiotherapy, endocrine therapy, or chemotherapy). 5. No history of allergy to dandelion or dandelion products. 6. ECOG performance status ≤ 2. 7. Plan to receive and maintain Androgen Deprivation Therapy (ADT) combined with an androgen receptor antagonist (e.g., enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other drugs inhibiting testosterone synthesis during the study period. 8. Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study Exclusion Criteria:…
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Expert commentary on why this trial matters and what to watch for.
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