NCT05076851

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Hongqian Guo · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-06-17
• Primary completion: 2021-12-31
• Completion: 2022-10-31
• First posted: 2021-10-13
• Last updated: 2021-10-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study