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Not yet recruiting NCT07389187

Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Early Phase I Interventional mCRPC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LC-K76, Tislelizumab, Standard Androgen Deprivation Therapy (ADT).
Who it may be relevant to
Registry conditions: mCRPC. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Overview

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 supplement LC-K76
    Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.
  • Drug Tislelizumab
    Intravenous infusion, 200 mg every 3 weeks (Q3W).
  • Drug Standard Androgen Deprivation Therapy (ADT)
    Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).

Primary outcome measures

  • Incidence of Adverse Events (AEs) [Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks]
Secondary outcome measures (4)
  • PSA Response Rate [Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks]
  • Disease control rate (DCR) [Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks]
  • Radiographic Progression-Free Survival (rPFS) [Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks]
  • Time to First Skeletal-Related Event (SRE) [Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks]

Eligibility criteria

Inclusion criteria

  • Male, aged 18 to 85 years.
  • Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.
  • 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.
  • Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).
  • Serum testosterone at castration levels (< 50 ng/dL or 1.75 nmol/L).
  • ECOG performance status ≤ 2.
  • Life expectancy > 6 months.
  • Adequate bone marrow, hepatic, and renal function.
  • Willing to undergo biopsies before and during treatment

Exclusion criteria

  • Lack of pathological evidence for prostate cancer.
  • Other primary malignant tumors active or requiring treatment within the past 3 years.
  • Has visceral metastases.
  • Poorly controlled diabetes after continuous insulin therapy.
  • 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) .
  • Severe cardiopulmonary disease or high-risk conditions.
  • Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1).
  • Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.
  • History of severe drug allergies.
  • Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea).
  • Concurrent psychiatric or neurological conditions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Changzheng hospital — Shanghai

Identifiers

NCT: NCT07389187 · LC-K76-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗