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

NCT07389174 | Not Yet Recruiting Early Phase 1

• 1 other identifier: LC-K76-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Adenocarcinoma; mHSPC; mHNPC

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• 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

Study Arms (4)

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.

Drug: Standard Endocrine Therapy

Interventions

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 .

High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy; High-Volume mHSPC: Standard of Care; Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy; Low-Volume mHSPC: Standard of Care

LC-K76 DIETARY_SUPPLEMENT

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.

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Changzheng hospital

Shanghai, Shanghai Municipality, 201109, China

Location

Central Study Contacts

Shancheng Ren, MD,PhD

CONTACT

86021-81886999; renshancheng@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Urology

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)