Safety and Efficacy Evaluation of LC-K76 in Patients With... | NCT07389174

NCT07389174

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-Volume mHSPC: Standard of Care	Active Comparator	Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.	Drug: Standard Endocrine Therapy
High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy	Experimental	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.	Drug: Standard Endocrine Therapy Dietary Supplement: LC-K76
Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy	Experimental	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.	Drug: Standard Endocrine Therapy Dietary Supplement: LC-K76
Low-Volume mHSPC: Standard of Care	Active Comparator	Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Endocrine Therapy	Drug	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 .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From baseline to primary completion, which may take up to 24 to 48 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	From baseline to primary completion, which may take up to 24 to 48 weeks
PSA Response Rate

Eligibility Module

Eligibility Criteria

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 ≤ 2.
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.
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.