Back to results

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

Primary Purpose

Neoadjuvant Therapy \High Risk Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

placebo

Proxalutamide

About this trial

This is an interventional treatment trial for Neoadjuvant Therapy \High Risk Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
Patients must be ≥ 18，male
Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
ECOG PS：0-1

Exclusion Criteria:

Imaging or biopsy confirmed distant Metastatic lesion
The number of regional lymph nodes metastasis >3
Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Sites / Locations

The Affiliated Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo group

Proxalutamide

Arm Description

placebo+ADT

Proxalutamide +ADT

Outcomes

Primary Outcome Measures

Pathologic Complete Response Rate

The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy

Proportion of Subjects With Minimal Residual Disease

The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy

Secondary Outcome Measures

Full Information

NCT ID

NCT05076851

First Posted

June 22, 2021

Last Updated

October 12, 2021

Sponsor

Hongqian Guo

1. Study Identification

Unique Protocol Identification Number

NCT05076851

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2021 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hongqian Guo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoadjuvant Therapy \High Risk Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Proxalutamide: androgen deprivation therapy（ADT）=2:1

Masking

Participant

Allocation

Randomized

Enrollment

2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

placebo+ADT

Arm Title

Proxalutamide

Arm Type

Experimental

Arm Description

Proxalutamide +ADT

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Proxalutamide

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathologic Complete Response Rate

Description

The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy

Time Frame

up to 6months

Title

Proportion of Subjects With Minimal Residual Disease

Description

The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy

Time Frame

up to 6months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study Patients must be ≥ 18，male Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma） High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml) Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection ECOG PS：0-1 Exclusion Criteria: Imaging or biopsy confirmed distant Metastatic lesion The number of regional lymph nodes metastasis >3 Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongqian Guo, Phd

Phone

+86-13605171690

dr.ghq@nju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Shun Zhang, Phd

Phone

+86-15050589789

explorershun@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongqian Guo, Phd

Organizational Affiliation

Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University

Official's Role

Study Chair

Facility Information:

Facility Name

The Affiliated Hospital of Nanjing University Medical School

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shun zhang, Doctor

Phone

15050589789

explorershun@126.com

First Name & Middle Initial & Last Name & Degree

Junlong Zhuang, Doctor

Phone

15950451917

zhuangjl-2008@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs