mHSPCEarly Phase 1NCT07389174
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
A Early Phase 1 study testing Standard Endocrine Therapy and LC-K76 in people with mHSPC and mHNPC, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- What is being tested?
- Standard Endocrine Therapy and LC-K76
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- No history of allergy to dandelion or dandelion products.
- ECOG performance status ≤ 2.
- 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.
- Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study
Who cannot join
- 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.
- Known or suspected central nervous system metastases or active leptomeningeal disease.
- 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$^2$.
Show all 13Show fewer
- Any severe disease affecting cardiopulmonary function or high-risk conditions.
- History of severe drug allergies.
- Presence of factors interfering with swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
- Concurrent psychiatric illness or neurological symptoms judged to make participation difficult.
- 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.
- Concurrent participation in other clinical trials or use of other investigational drugs.
- Refusal or inability to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changzheng hospital
Shanghai, Shanghai Municipality, 201109
Shancheng Ren, PhD, 86021-81886999, renshancheng@gmail.com
About this study
Official title: An Open-Label, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 in Combination With Endocrine Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
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.
- Conditions
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- Being tested
- Standard Endocrine Therapy, LC-K76
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Endocrine TherapyDrug
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 .
LC-K76Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Volume mHSPC: Standard of Care | Active comparator | Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone. Receives: Drug: Standard Endocrine Therapy |
| High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy | Experimental | Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). High volume is defined as the presence of visceral metastases or ≥ 4 bone lesions with ≥ 1 beyond the vertebral bodies and pelvis. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy. Receives: Drug: Standard Endocrine Therapy; Dietary Supplement: LC-K76 |
| Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy | Experimental | Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Low volume is defined as ≤ 3 bone metastases confined to the vertebral bodies and pelvis, and no visceral metastases. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy. Receives: Drug: Standard Endocrine Therapy; Dietary Supplement: LC-K76 |
| Low-Volume mHSPC: Standard of Care | Active comparator | Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone. Receives: Drug: Standard Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Secondary outcomes (5)
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
PSA Response Rate
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Time to CRPC（Castration-Resistant Prostate Cancer）
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
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) .
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Radiographic Progression-Free Survival （rPFS ）
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.
Measured: From baseline to primary completion, which may take up to 24 to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mHSPCStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Shancheng, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389174
- Sponsor's protocol ID
- LC-K76-101
- Status last verified
- Feb 2026
- First submitted
- 28 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 in Combination With Endocrine Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07389174
- Acronym / sponsor ID
- LC-K76-101
- Conditions
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-Volume mHSPC: Standard of Care | Active comparator | Drug: Standard Endocrine TherapyParticipants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone. |
| High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy | Experimental | Drug: Standard Endocrine Therapy, Dietary Supplement: LC-K76Participants with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). High volume is defined as the presence of visceral metastases or ≥ 4 bone lesions with ≥ 1 beyond the vertebral bodies and pelvis. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy. |
| Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy | Experimental | Drug: Standard Endocrine Therapy, Dietary Supplement: LC-K76Participants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Low volume is defined as ≤ 3 bone metastases confined to the vertebral bodies and pelvis, and no visceral metastases. Participants in this arm receive oral LC-K76 combined with standard-of-care endocrine therapy. |
| Low-Volume mHSPC: Standard of Care | Active comparator | Drug: Standard Endocrine TherapyParticipants with low-volume metastatic hormone-sensitive prostate cancer (mHSPC). Participants in this arm receive standard-of-care endocrine therapy alone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- No history of allergy to dandelion or dandelion products.
Key exclusion criteria (13 listed)
- 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.
- Known or suspected central nervous system metastases or active leptomeningeal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Endocrine TherapyParticipants 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 . | Drug | High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy, High-Volume mHSPC: Standard of Care, Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy, Low-Volume mHSPC: Standard of Care |
| LC-K76Oral 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. | Dietary supplement | High-Volume mHSPC: LC-K76 + Standard Endocrine Therapy, Low-Volume mHSPC: LC-K76 + Standard Endocrine Therapy |
Primary outcome
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.
5 secondary outcomes
PSA Undetectable Rate
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
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
Radiographic Progression-Free Survival （rPFS ）
Time frame: From baseline to primary completion, which may take up to 24 to 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for mHSPC
RecruitingObservational study
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
RecruitingPhase 3
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Prostate Cancer, mHSPC
Active, not recruitingPhase 3
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Prostate Cancer
Active, not recruitingPhase 3
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Prostatic Neoplasms
RecruitingObservational study
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Standard Endocrine Therapy and LC-K76 in people with mHSPC and mHNPC, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shancheng Ren, MD,PhD (86021-81886999, renshancheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From baseline to primary completion, which may take up to 24 to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.