Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer

Study Overview
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Brief Summary
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This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,

Official Title
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A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer

Conditions
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Neoadjuvant Therapy \High Risk Prostate Cancer

Intervention / Treatment
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* Other: placebo
* Drug: Proxalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study Patients must be ≥ 18，male Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma） High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml) Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection ECOG PS：0-1 Exclusion Criteria: Imaging or biopsy confirmed distant Metastatic lesion The number of regional lymph nodes metastasis >3 Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Proxalutamide: androgen deprivation therapy（ADT）=2:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>placebo+ADT | Other: placebo<br>* placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD<br>|
| Experimental: Proxalutamide<br>Proxalutamide +ADT | Drug: Proxalutamide<br>* Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response Rate | The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy | up to 6months | 
| Proportion of Subjects With Minimal Residual Disease | The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy | up to 6months |