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.
Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;
Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;
PSA < 0.1 ng/ml within 8 weeks after surgery;
Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;
Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;
Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;
Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;
Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);
Single group
Apalutamide 60mg Tab
DrugApalutamide 60Mg Tab (4 x 60 mg) once daily on days 1-28 of a 28-day cycle
Androgen deprivation therapy(ADT)
DrugThe choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Two-year biochemical progression-free survival
It is defined as the proportion of patients without biochemical progression or death 2 year after initiation with Apalutamide plus ADT. Biochemical progression is defined as an increase of more than 0.5 ng/mL from PSA nadir after treatment (confirmed rise on at least two separate occasions) or any evidence of clinical relapse/metastasis or the initiation of any anti-prostate cancer therapy or death due to any cause.
Event-free survival rate
It is defined as the proportion of patients without biochemical recurrence or any evidence of clinical relapse/metastasis or initiation of any other anti-prostate cancer therapy or death due to any cause.
Biochemical progression-free survival
It is defined as the time from the initiation of treatment to the first occurrence of biochemical recurrence, and the definition of biochemical progression is the same as that of the primary observation endpoint;
Metastasis-free survival (MFS)
It is defined as the time from the start of treatment to the first occurrence of distant metastasis or death, whichever occurs first; distant metastasis can be diagnosed by imaging results or pathology by Blinded Independent Central Review (BICR);
Quality of life (QoL) assessed by FACT-P scale
The FACT-P scale (39 items) includes a Functional Assessment of Cancer Therapy - General (FACT-G, which consists of 4 subscales measuring physical, functional, social/family, and emotional well-being) and a specific subscale for prostate cancer. The total score is calculated by summing the scores of FACT-G and the prostate cancer subscales, ranging from 0 to 156, with higher scores indicating better functional status
Click on the lead sponsor to view all of their trials.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Xian-Janssen Pharmaceutical Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
