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

October 12, 2021 updated by: Hongqian Guo

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

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,

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affiliated Hospital of Nanjing University Medical School
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6months
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
up to 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongqian Guo

Investigators

  • Study Chair: Hongqian Guo, Phd, Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-GT0918-CN-1008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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