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
Qualifiers
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
Treatments tested in this trial
- Standard Endocrine Therapy
- LC-K76
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov