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

NCT05076851 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-10-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hongqian Guo

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2021-12-31
Completion
2022-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076851 on ClinicalTrials.gov