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

Sponsor

Hongqian Guo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05076851

Collaborator

(none)

Enrollment

Location

Arms

16.5

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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,

Condition or Disease	Intervention/Treatment	Phase
Neoadjuvant Therapy \High Risk Prostate Cancer	Other: placebo Drug: Proxalutamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 17, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

Hongqian Guo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongqian Guo, chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

ClinicalTrials.gov Identifier:

NCT05076851

Other Study ID Numbers:

IIT-GT0918-CN-1008

First Posted:

Oct 13, 2021

Last Update Posted:

Oct 13, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Oct 13, 2021