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Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

NCT05249712 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-03

No results posted yet for this study

Summary

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Darolutamide combined with Androgen-Deprivation Therapy in High-risk/Very high-risk localized prostate cancer. This trial is A prospective, single-arm, multicenter clinical trial. Treatment cycle is 24 weeks,

Conditions

Interventions

DRUG

Darolutamide 300 mg

600 mg (300 mg × 2 tablets) twice daily with meals, equivalent to a total daily dose of 1200 mg.

OTHER

Androgen deprivation therapy

The ADT regimen used by each patient will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescribing information.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Hongqian Guo, Phd · Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-01-01
Completion
2025-12-01

Countries

  • China

More Related Trials

Entities

Diseases

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 NCT05249712 on ClinicalTrials.gov