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
Overview
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Shanghai Changzheng Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events (AEs)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male, aged ≥ 18 years.
- •Histologically or cytologically confirmed newly diagnosed metastatic hormone-sensitive prostate adenocarcinoma, without small cell carcinoma or small cell components.
- •Presence of at least one bone metastasis or visceral metastasis (excluding lymph nodes) detected by systemic imaging (CT/MRI).
- •No prior treatment for prostate cancer before enrollment (including but not limited to radical surgery, radiotherapy, endocrine therapy, or chemotherapy).
- •No history of allergy to dandelion or dandelion products.
- •ECOG performance status ≤
- •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.
- •Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study
Exclusion Criteria
- •Lack of pathological evidence for prostate cancer diagnosis.
- •Prior receipt of any treatment modality for prostate cancer.
- •Patients with other primary malignant tumors that were progressive or required active treatment within the past 3 years.
- •Patients with diabetes requiring continuous insulin therapy or poorly controlled diabetes.
- •Known or suspected central nervous system metastases or active leptomeningeal disease.
- •Significant abnormalities in bone marrow, coagulation, renal, and hepatic function, defined as laboratory values at randomization: Hemoglobin \< 90 g/L, Neutrophils \< 1.5 × 10$\^9$/L, Platelets \< 75 × 10$\^9$/L, ALT \> 2.5 × ULN, AST \> 2.5 × ULN, or Serum Total Bilirubin \> 1.5 × ULN; eGFR \< 60 mL/min/1.73m$\^2$.
- •Any severe disease affecting cardiopulmonary function or high-risk conditions.
- •History of severe drug allergies.
- •Presence of factors interfering with swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
- •Concurrent psychiatric illness or neurological symptoms judged to make participation difficult.
Arms & Interventions
High-Volume mHSPC: Standard of Care
Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.
Intervention: Standard Endocrine Therapy (Drug)
High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy
Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). High volume is defined as the presence of visceral metastases or ≥ 4 bone lesions with ≥ 1 beyond the vertebral bodies and pelvis. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy.
Intervention: Standard Endocrine Therapy (Drug)
High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy
Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). High volume is defined as the presence of visceral metastases or ≥ 4 bone lesions with ≥ 1 beyond the vertebral bodies and pelvis. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy.
Intervention: LC-K76 (Dietary Supplement)
Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy
Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Low volume is defined as ≤ 3 bone metastases confined to the vertebral bodies and pelvis, and no visceral metastases. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy.
Intervention: Standard Endocrine Therapy (Drug)
Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy
Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Low volume is defined as ≤ 3 bone metastases confined to the vertebral bodies and pelvis, and no visceral metastases. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy.
Intervention: LC-K76 (Dietary Supplement)
Low-Volume mHSPC: Standard of Care
Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.
Intervention: Standard Endocrine Therapy (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Events (AEs)
Time Frame: From baseline to primary completion, which may take up to 24 to 48 weeks
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.
Secondary Outcomes
- PSA Undetectable Rate(From baseline to primary completion, which may take up to 24 to 48 weeks)
- PSA Response Rate(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Time to CRPC（Castration-Resistant Prostate Cancer）(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Disease Control Rate (DCR)(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Radiographic Progression-Free Survival （rPFS ）(From baseline to primary completion, which may take up to 24 to 48 weeks)
Investigators
Ren Shancheng
Professor, Chief of Urology
Shanghai Changzheng Hospital