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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Any condition that, in the judgment of the investigator, poses a severe safety risk to the patient, may confound study results, or may affect the patient's ability to complete the study (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders), or any other relevant conditions.
- •Concurrent participation in other clinical trials or use of other investigational drugs.
- •Refusal or inability to sign the informed consent form.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Standard Endocrine Therapy (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: 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.
次要结局
- 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)
研究者
Ren Shancheng
Professor, Chief of Urology
Shanghai Changzheng Hospital