Overview

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