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

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: Male

Summary

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,

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hongqian Guo

Criteria

Inclusion Criteria:

1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study

2. Patients must be ≥ 18，male

3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）

4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)

5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection

6. ECOG PS：0-1

Exclusion Criteria:

1. Imaging or biopsy confirmed distant Metastatic lesion

2. The number of regional lymph nodes metastasis >3

3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer

4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy