Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Androgens

Hormones

Hormone Antagonists

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

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

Apalutamide 60mg Tab

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

Androgen deprivation therapy(ADT)

Hongqian Guo, PhD

Luwei Xu

Shun Zhang, PhD

Xuefeng Qiu, PhD

Xiaolin Wang

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.

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)

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.

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.

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;

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);

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

It is defined as the proportion of patients with testosterone recovery 2 year after initiation of apalutamide plus ADT. Testosterone recovery is defined as testosterone level \>50 ng/dL.

Testosterone recovery is defined as testosterone level \>50 ng/dL

All adverse events (AEs) are assessed and graded according to NCI-CTCAE v5.0. Safety will be assessed and documented after the initiation of study drug, regardless of relationship to the study drug, until 30 days after the last study treatment or the initiation of new antineoplastic therapy, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)	NCT05778097	Prostate Cancer Biochemical Rec... High Risk	Apalutamide 60m... Androgen depriv...	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)	NCT05778097	Prostate Cancer Biochemical Rec... High Risk	Apalutamide 60m... Androgen depriv...	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for prostate cancer biochemical recurrence