Trials / Not Yet Recruiting
Not Yet RecruitingNCT05778097
Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2026-08-31
- Completion
- 2026-12-31
- First posted
- 2023-03-21
- Last updated
- 2023-03-21
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05778097. Inclusion in this directory is not an endorsement.