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

NCT05076851 | Unknown Phase 2 FDA Drug

• 1 other identifier: IIT-GT0918-CN-1008
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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,

Conditions

Neoadjuvant Therapy \High Risk Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response Rate

  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

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

  up to 6months

Study Arms (2)

placebo group

PLACEBO COMPARATOR

placebo+ADT

Other: placebo

Proxalutamide

EXPERIMENTAL

Proxalutamide +ADT

Drug: Proxalutamide

Interventions

placebo OTHER

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

placebo group

Proxalutamide DRUG

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

Proxalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hongqian Guo: lead

Study Sites (1)

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

proxalutamide

Study Officials

• Hongqian Guo, Phd

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

  STUDY CHAIR

Central Study Contacts

Hongqian Guo, Phd

CONTACT

+86-13605171690; dr.ghq@nju.edu.cn

Shun Zhang, Phd

CONTACT

+86-15050589789; explorershun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

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

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: October 13, 2021
• Study Start: June 17, 2021
• Primary Completion: December 31, 2021
• Study Completion: October 31, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

CN (1)