This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate cancer receiving oral LC-K76 treatment. Following a screening period not exceeding three weeks, subjects will enter a one- to two-week matching and randomization phase. Subsequently, subjects will be assigned to receive the study drug for a 24-week treatment period, followed by a 24-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants in this arm receive the standard-of-care endocrine therapy for metastatic hormone-sensitive prostate cancer (mHSPC). This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor (e.g., Apalutamide, Enzalutamide, Darolutamide, Rezvilutamide, or Abiraterone Acetate). The specific choice of drugs is determined by the investigator based on approved clinical use .
Oral administration at a dose of 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner, for a treatment period of 24 weeks.
Changzheng hospital
Shanghai, Shanghai Municipality, China
Incidence of Adverse Events (AEs)
The Incidence of Adverse Events is defined as the proportion of subjects in a clinical trial who experience at least one Adverse Event (AE) during the defined observation period, which is assessed by CTCAE 5.0.
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
PSA Undetectable Rate
Percentage of participants who convert from detectable PSA (≥ 0.2 ng/mL) at baseline to undetectable PSA (\< 0.2 ng/mL) during the study.
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
PSA Response Rate
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Time to CRPC(Castration-Resistant Prostate Cancer)
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Disease Control Rate (DCR)
Defined as the proportion of subjects whose best overall response, assessed per standardized criteria (RECIST 1.1 and PCWG3), is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) .
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Radiographic Progression-Free Survival (rPFS )
Defined as the time from randomization to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first.
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
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