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

Phase 2

• Conditions: Neoadjuvant Therapy \High Risk Prostate Cancer
• Interventions: Drug: Proxalutamide; Other: placebo

• Registration Number: NCT05076851
• Lead Sponsor: Hongqian Guo

Brief 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,

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-17
• Study First Submitted: 2021-06-22
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proxalutamide	Proxalutamide	Proxalutamide +ADT
placebo group	placebo	placebo+ADT

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China