Prostate Cancer
Conditions
Interventions
Experimental Group:Rezvilutamide + ADT
Sponsors
The First Affiliated Hospital of AFMU (Xijing Hospital)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Histologically confirmed locally advanced prostate adenocarcinoma 3. Locally advanced stage confirmed by PSMA PET/CT: T3-4N0M0 or T any N1M0 4. Deemed suitable for radical prostatectomy by the investigator 5. ECOG performance status 0 or 1 (Eastern Cooperative Oncology Group) 6. Adequate organ function: Hemoglobin >=10.0 g/dL (without transfusion support) Absolute neutrophil count (ANC) >=1.5×10^9/L Platelets >=100×10^9/L Serum potassium >=3.5 mmol/L Total bilirubin 1.5×ULN) AST/ALT = 3.5 g/dL Serum creatinine <1.5×ULN PT/aPTT <= 1.5×ULN 7. Willingness to receive anti-androgen therapy 8. Ability to swallow whole tablets 9. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with small cell or sarcomatoid pathological features 2.Diagnosis of composite prostate carcinoma by biopsy 3.Presence of extrapelvic lymph node, bone, or visceral metastases (any M1 stage) 4.Prior androgen deprivation therapy (medical/surgical) or local prostate cancer treatment (radiotherapy/chemotherapy) 5.Receipt of other investigational drugs within 4 weeks or major surgery within 4 weeks before enrollment 6.Conditions compromising drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction) 7.Known hypersensitivity to rezvilutamide, LHRH antagonists, or their components 8.Severe or uncontrolled concurrent infections 9.History of epilepsy or seizure-inducing conditions within 12 months 10.Congenital immunodeficiency, organ transplantation, or HIV positivity 11.Other malignancies within 3 years (excluding cured carcinoma in situ or indolent malignancies per investigator assessment) 12.Cardiovascular exclusions: NYHA Class III/IV heart failure Thromboembolic events, unstable angina, or myocardial infarction within 6 months Clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, fibrillation, torsades de pointes) QTcF interval >470 ms on screening ECG 13. Uncontrolled hypertension (SBP >=160 mmHg or DBP >= 100 mmHg) 14.Concurrent participation in other interventional clinical studies 15.Failure to provide informed consent 16.Other conditions deemed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pCR;Rate of PSM; | — |
Secondary
| Measure | Time frame |
|---|---|
| MFS;PSA response rate;Tumor Volume Reduction Rate;Time to biochemical relapse;safety; | — |
Countries
China
Contacts
Public ContactQin weijun
The First Affiliated Hospital of AFMU (Xijing Hospital)
Outcome results
None listed