Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Conditions
Interventions
Control group:ADT combined with enzalutamide 160mg once daily
Treatment group:ADT combined with Enzalutamide 160 mg once daily, supplemented with Kidney Qi Pills (9g [12 pills] per dose, once daily, taken orally at dusk).
Sponsors
The First Affiliated Hospital of Hunan University of Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Males aged 18 years or older; - Meeting diagnostic criteria for metastatic hormone-sensitive prostate cancer (mHSPC): pathologically confirmed prostate cancer + imaging-confirmed metastasis + no prior ADT initiation or, if ADT initiated, treatment-responsive (persistently low/declining PSA, symptom relief, imaging stability) with no biochemical or imaging progression to CRPC. - Planned to receive standard ADT combined with enzalutamide therapy; - ECOG performance status 0-2; - Expected survival = 6 months; - Signed informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Previous treatment with NHA; - Concurrent malignancies; - Severe hepatic or renal impairment; - Central nervous system metastases; - Allergy to any component of the study drug; - Contraindications to traditional Chinese medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life (Patient-Reported Outcomes); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Metrics;Overall Survival (OS);Radiographic progression-free survival (rPFS);PSA response rate;Chinese Medicine Syndrome Symptom Score for Prostate Cancer; | — |
Countries
China
Contacts
Public ContactQing Zhou
The First Affiliated Hospital of Hunan University of Chinese Medicine
Outcome results
None listed