mCRPC
Conditions
Brief summary
This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.
Interventions
DIETARY_SUPPLEMENTLC-K76
Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.
DRUGTislelizumab
Intravenous infusion, 200 mg every 3 weeks (Q3W).
DRUGStandard Androgen Deprivation Therapy (ADT)
Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male, aged 18 to 85 years. 2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components. 3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and/or docetaxel chemotherapy. 4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT). 5. Serum testosterone at castration levels (\< 50 ng/dL or 1.75 nmol/L). 6. ECOG performance status ≤ 2. 7. Life expectancy \> 6 months. 8. Adequate bone marrow, hepatic, and renal function. 9. Willing to undergo biopsies before and during treatment
Exclusion criteria
1. Lack of pathological evidence for prostate cancer. 2. Other primary malignant tumors active or requiring treatment within the past 3 years. 3. Has visceral metastases. 4. Poorly controlled diabetes after continuous insulin therapy. 5. Significant abnormalities in laboratory values at randomization (Hb \< 90 g/L; Neutrophils \< 1.5x10\^9/L; Platelets \< 75x10\^9/L; ALT/AST \> 2.5xULN; Bilirubin \> 1.5xULN; eGFR \< 60 mL/min/1.73m\^2) . 6. Severe cardiopulmonary disease or high-risk conditions. 7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1). 8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts. 9. History of severe drug allergies. 10. Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea). 11. Concurrent psychiatric or neurological conditions
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 Response Rate | 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 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 treatment initiation to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first. |
| Time to First Skeletal-Related Event (SRE) | From baseline to primary completion, which may take up to 24 to 48 weeks | Defined as the interval from the date of treatment initiation to the date of the first occurrence of any of the following clinically significant events attributable to bone metastasis: pathological fracture (vertebral or non-vertebral), palliative radiation therapy to bone for pain relief, surgical intervention to bone to prevent or treat a fracture or spinal cord compression, or confirmed spinal cord compression. |
Countries
China
Contacts
CONTACTRen, MD,PhD
Outcome results
None listed