Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC

Study Overview
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Brief Summary
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Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.

Detailed Description
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To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.

Official Title
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A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Conditions
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Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Chemotherapy Effect

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Rezvilutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged ≥40 years and ≤80 years. Histologically or cytologically confirmed prostate adenocarcinoma. Metastatic disease. Eligible for ADT and Docetaxel. Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization. ECOG score of 0 or 1. Laboratory tests meet the following requirements: Hematology: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥9g/dL. Renal function: serum creatinine ≤1.5× upper limit of normal (ULN). Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN. Coagulation function: international normalized ratio (INR) <1.5. Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions: 1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine). 2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes). Exclusion Criteria: Patients who meet any of the following criteria are not eligible to participate in this study: Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization. Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization. Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV). Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization. Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment. Inability to take oral medication.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rezvilutamide+ADT+Docetaxel<br>Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. Docetaxel 6 cycles | Drug: Docetaxel<br>* This is Triple drug regimen for mHSPC<br>* Other names: Rezvilutamide;|
| Active Comparator: Rezvilutamide+ADT<br>Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food. | Drug: Rezvilutamide<br>* This is doubling drug regimen for mHSPC<br>* Other names: ADT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rPFS | radiographic Progression-Free Survival | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate-specific antigen (PSA) response rate | percentage of patients with a decreasing PSA following the regimens discussed above | 36 months | 
| time to castration-resistant prostate cancer (CRPC) | time to PSA progression | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rezvilutamide, mHPSC, chemotherapy, Androgen deprivation therapy