Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer

Naval Military Medical University (Second Military Medical University)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: mHSPC; mHNPC; Prostate Cancer Adenocarcinoma

Treatments: Dietary Supplement: LC-K76; Drug: Standard Endocrine Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07389174

LC-K76-101

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male, aged ≥ 18 years.
2. Histologically or cytologically confirmed newly diagnosed metastatic hormone-sensitive prostate adenocarcinoma, without small cell carcinoma or small cell components.
3. Presence of at least one bone metastasis or visceral metastasis (excluding lymph nodes) detected by systemic imaging (CT/MRI).
4. No prior treatment for prostate cancer before enrollment (including but not limited to radical surgery, radiotherapy, endocrine therapy, or chemotherapy).
5. No history of allergy to dandelion or dandelion products.
6. ECOG performance status ≤ 2.
7. 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.
8. Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study

Exclusion criteria

1. Lack of pathological evidence for prostate cancer diagnosis.
2. Prior receipt of any treatment modality for prostate cancer.
3. Patients with other primary malignant tumors that were progressive or required active treatment within the past 3 years.
4. Patients with diabetes requiring continuous insulin therapy or poorly controlled diabetes.
5. Known or suspected central nervous system metastases or active leptomeningeal disease.
6. 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$^2$.
7. Any severe disease affecting cardiopulmonary function or high-risk conditions.
8. History of severe drug allergies.
9. Presence of factors interfering with swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
10. Concurrent psychiatric illness or neurological symptoms judged to make participation difficult.
11. 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.
12. Concurrent participation in other clinical trials or use of other investigational drugs.
13. Refusal or inability to sign the informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

High-Volume mHSPC: Standard of Care

Active Comparator group

Description:

Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.

Treatment:

Drug: Standard Endocrine Therapy

High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy

Experimental group

Description:

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.

Treatment:

Drug: Standard Endocrine Therapy

Dietary Supplement: LC-K76

Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy

Experimental group

Description:

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.

Treatment:

Drug: Standard Endocrine Therapy

Dietary Supplement: LC-K76

Low-Volume mHSPC: Standard of Care

Active Comparator group

Description:

Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone.

Treatment:

Drug: Standard Endocrine Therapy