Current partner codePEPTIDESDE
NCT07389174·Early Phase 1·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Early Phase 1

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Standard Endocrine Therapy

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_SUPPLEMENT

LC-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.

Timeline

From registration to results.

  1. First posted

    Feb 5, 2026

  2. Study start

    Feb 2026

  3. Primary completion

    Jan 2027

  4. Study completion

    Jun 2027

  5. Results posted

    Not reported

  6. Registry updated

    Feb 5, 2026

Outcomes

What the study measures.

Primary outcomes

Incidence of Adverse Events (AEs)

Time frame · 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 outcomes

PSA Undetectable Rate

Time frame · 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

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

Time to CRPC(Castration-Resistant Prostate Cancer)

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

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 )

Time frame · 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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
MALE
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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Changzheng hospital

Shanghai, Shanghai Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

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