Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-85
SponsorShanghai Changzheng Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Endocrine Therapy
DrugParticipants 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 .
LC-K76
Dietary supplementOral 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: High-Volume mHSPC: Standard of CareActive comparator 1 intervention
Group B: High-Volume mHSPC: LC-K76 + Standard Endocrine TherapyExperimental treatment 2 interventions
Group C: Low-Volume mHSPC: LC-K76 + Standard Endocrine TherapyExperimental treatment 2 interventions
Group D: Low-Volume mHSPC: Standard of CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
From baseline to primary completion, which may take up to 24 to 48 weeksSecondary outcomes
1
PSA Undetectable Rate
Percentage of participants who convert from detectable PSA (≥ 0.2 ng/mL) at baseline to undetectable PSA (\< 0.2 ng/mL) during the study.
Time frame
From baseline to primary completion, which may take up to 24 to 48 weeks2
PSA Response Rate
Time frame
From baseline to primary completion, which may take up to 24 to 48 weeks3
Time to CRPC（Castration-Resistant Prostate Cancer）
Time frame
From baseline to primary completion, which may take up to 24 to 48 weeks4
Disease Control Rate (DCR)
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) .
Time frame
From baseline to primary completion, which may take up to 24 to 48 weeksSponsors and contacts
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Source ClinicalTrials.gov
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