NCT07389174

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• mHSPC
• mHNPC
• Prostate Cancer Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Standard Endocrine Therapy	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 .
DIETARY_SUPPLEMENT	LC-K76	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: China