mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
Conditions
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.
Interventions
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 .
DIETARY_SUPPLEMENTLC-K76
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.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | 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
| Measure | Time frame | Description |
|---|---|---|
| PSA Undetectable Rate | From baseline to primary completion, which may take up to 24 to 48 weeks | Percentage of participants who convert from detectable PSA (≥ 0.2 ng/mL) at baseline to undetectable PSA (\< 0.2 ng/mL) during the study. |
| 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 | Defined as the proportion of subjects whose best overall response, assessed per standardized criteria (RECIST 1.1 and PCWG3), is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) . |
| Radiographic Progression-Free Survival （rPFS ） | From baseline to primary completion, which may take up to 24 to 48 weeks | Defined as the time from randomization to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first. |
Countries
China
Contacts
CONTACTShancheng Ren, MD,PhD
Outcome results
None listed