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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

April 1, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Prostate CancerBiochemical RecurrenceHigh Risk
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.

Trial Locations (3)

210001

Nanjing First Hospital, Nanjing Medical University, Nanjing

210008

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

226002

Nanjing Tumor Hospital, Nantong

All Listed Sponsors
collaborator

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

NCT05778097 - Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study) | Biotech Hunter | Biotech Hunter