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

Overview

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,

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Other: placebo
    • placebo+ADT(Androgen Deprivation Therapy) ,Route of placebo administration: tablet, dosage:300mg , dosage form oral , frequency of administration:QD
  • Drug: Proxalutamide
    • Proxalutamide +ADT(Androgen Deprivation Therapy) ,Route of Proxalutamide administration: tablet, dosage:300mg , dosage form oral , frequency of administration:QD

Arms, Groups and Cohorts

  • Placebo Comparator: placebo group
    • placebo+ADT
  • Experimental: Proxalutamide
    • Proxalutamide +ADT

Clinical Trial Outcome Measures

Primary Measures

  • Pathologic Complete Response Rate
    • Time Frame: 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
    • Time Frame: up to 6months
    • The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hongqian Guo
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Hongqian Guo, chief physician – The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Overall Official(s)
    • Hongqian Guo, Phd, Study Chair, Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
  • Overall Contact(s)
    • Hongqian Guo, Phd, +86-13605171690, dr.ghq@nju.edu.cn

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