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NOT YET RECRUITING
NCT05778097
PHASE2

Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

ARES is a multicenter, single-arm, phase 2 trial to evaluate the efficacy and safety of ADT in combination with apalutamide as an adjuvant regimen for patients with high risk of recurrence after radical prostatectomy.

Official title: Adjuvant Androgen Deprivation Therapy Combined With Apalutamide for Prostate Cancer Patients Post Radical-prostatectomy With High-risk of Reoccurrence: a Prospective, Single-arm, Multicenter Trial (ARES Study)

Key Details

Gender

MALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2023-04-01

Completion Date

2026-12-31

Last Updated

2023-03-21

Healthy Volunteers

No

Interventions

DRUG

Apalutamide 60mg Tab

Apalutamide 60Mg Tab (4 x 60 mg) once daily on days 1-28 of a 28-day cycle

DRUG

Androgen deprivation therapy(ADT)

The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Locations (3)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Nanjing Tumor Hospital

Nantong, Jiangsu, China