prostate cancer
Conditions
Interventions
Queue 1:Enrolled patients will receive rezvilutamide combined with ADT + cRP + extended pelvic lymph node dissection. Patients will receive rezvilutamide, with a 28-day supply given every 4 weeks for
Queue 2:Enrolled patients will receive rezvilutamide combined with ADT and docetaxel + cRP + extended pelvic lymph node dissection. Patients will receive rezvilutamide, with a 28-day supply given ever
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The participant is willing to join this study, has the intention of surgery, has signed the informed consent form, is compliant and is willing to cooperate with follow-up. 2. Age: >=18 years when signing the informed consent. 3. Histologically or cytologically confirmed prostate adenocarcinoma. 4. Eastern Cooperative Oncology Group (ECOG) performance status = 1 year. 5. Confirmed by conventional imaging (such as bone scans, MRI/CT) within 4 weeks before enrollment, with = 90 g/L; b. Absolute neutrophil count (ANC) >= 1500/µL; c. Platelet count >= 100 * 10^9/L; d. Serum potassium >= 3.5 mmol/L; e. Alanine aminotransferase (ALT) = 1.5 × ULN; left ventricular ejection fraction (LVEF) >= 50%. f. Serum albumin >= 30 g/L. 7. If the participant's partner is a woman of childbearing potential, the participant agrees to use effective contraception during the treatment period and for 16 weeks after surgery.
Exclusion criteria
Exclusion criteria: 1. Prostate pathology results indicate neuroendocrine prostate cancer, including small cell carcinoma. 2. Patients with any of the following criteria will be excluded from this study: a. Prior receipt of androgen deprivation therapy (ADT), chemotherapy, surgery, external beam radiation, brachytherapy, radiopharmaceuticals, or experimental local treatments (such as radiofrequency ablation, cryotherapy, high-intensity focused ultrasound, etc.) for prostate cancer, except that up to 12 weeks of ADT (medical or surgical castration) with or without first-generation anti-androgens (e.g., flutamide, bicalutamide, etc.) before C1D1 is allowed; subjects using first-generation anti-androgens must discontinue them during the study treatment period, and there must be no evidence of radiographic disease progression or clinically significant PSA rise (defined as a >=50% increase in PSA from the nadir after serum testosterone has reached castrate levels) before C1D1. b. Prior use or planned use during the study of second-generation androgen receptor antagonists (e.g., enzalutamide, apalutamide, darolutamide, ARN-509, ODM-201, etc.), ketoconazole, abiraterone acetate, or other investigational drugs that inhibit androgen synthesis (e.g., TAK-700) for prostate cancer. c. Receipt of any of the following treatments within 4 weeks before C1D1: · Estrogens, progestins, androgens, or systemic steroid therapy (except for short-term use for anti-allergic purposes); · Herbal medicines known to have anti-prostate cancer effects or to lower PSA levels (e.g., saw palmetto). 3. Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg). 4. Active or symptomatic viral hepatitis or other chronic liver diseases, or known HIV infection. 5. History of pituitary or adrenal insufficiency. 6. Active autoimmune diseases requiring hormone therapy. 7. Clinically significant heart disease, including: myocardial infarction or arterial thrombosis within the past 24 weeks; severe or unstable angina pectoris; New York Heart Association (NYHA) Class III or IV heart disease; atrial fibrillation or other arrhythmias requiring treatment. 8. Participation in another drug clinical trial within 12 weeks before the first dose of chemotherapy in this study. 9. History of hypersensitivity to taxanes or docetaxel. 10. Concomitant treatment with potent CYP3A4 inhibitors is needed. 11. Any other malignancy within 5 years before C1D1, except for completely resolved in situ cancers and slowly progressing malignancies as determined by the investigator. 12. Any other condition, as judged by the investigator, that may seriously jeopardize the patient's safety, confound the study results, or interfere with the patient's ability to complete the study (e.g., severe diabetes, neurological or psychiatric disorders, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to deterioration in ECOG performance status;Prostate volume reduction rate;Minimal residual disease rate;Major pathological response rate;One-year biochemical progressionfree survival rate;Overall survival;Radiographic progression-free survival;Time to PSA progression;Quality of life assessment;PSA response rate;Time to CRPC; | — |
Countries
China
Contacts
Public ContactChen Wei
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed