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
Study ID
NCT05778097
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide 60mg Tab — DRUG
    Apalutamide 60Mg Tab (4 x 60 mg) once daily on days 1-28 of a 28-day cycle
  • Androgen deprivation therapy(ADT) — DRUG
    The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Mar 2023
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
103 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide+ADT
    Apalutamide (240 mg once daily) in combination with ADT for 12 cycles (28 days of each cycle)

Primary Outcome Measure

Two-year biochemical progression-free survival [ Time Frame: 24 months ]

Central Contacts

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