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

NCT05778097 | Not Yet Recruiting Phase 2

• 1 other identifier: IUNU-PC-115
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

Brief 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

Prostate Cancer; Biochemical Recurrence; High Risk

Keywords

prostate cancer biochemical recurrence; apalutamide; adjuvant treatment; post-radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (7)

• Event-free survival rate

  from initiation with apalutamide up to 36 months

• Biochemical progression-free survival

  60 months

• Metastasis-free survival (MFS)

  60 months

• Quality of life (QoL) assessed by FACT-P scale

  24 months

• Two-year testosterone recovery rate

  24 months

Study Arms (1)

Apalutamide+ADT

EXPERIMENTAL

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

Drug: Apalutamide 60mg Tab; Drug: Androgen deprivation therapy(ADT)

Interventions

Apalutamide 60mg Tab DRUG

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

Apalutamide+ADT

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.

Apalutamide+ADT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG score at 0-1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale;
• Adequate organ functions:
• Hematology (within 14 days before treatment: no blood transfusion, no use of granulocyte colony-stimulating factor, no use of other drugs for correction)：
• Neutrophil count (NE) ≥1.5×109/L;
• Hemoglobin (HGB) ≥ 90 g/L;
• Platelet count (PLT) ≥100×109/L; Coagulation function (no blood product transfusion within 14 days before treatment): international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× upper limit of normal (ULN); Blood biochemistry (liver and kidney function)：
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• Creatinine clearance ≥ 30 mL/min;
• Total bilirubin (TBIL) ≤ 1.5× ULN;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;
• Ability to provide written informed consent form (ICF) and ability to understand and agree to adhere to study requirements and schedule of assessments;

You may not qualify if:

• 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.);
• Any major surgery (other than radical resection) requiring general anesthesia within 28 days prior to the first dose of the study;
• Other malignancies present or occurred in the past 2 years, except cured non-melanoma skin cancers and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating of basement membrane);
• Arterial/venous thrombotic events (such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism) or anticoagulant therapy with warfarin or heparin within 6 months before the study;
• Corrected QT interval (QTc) of heart rate \> 500 ms; patients with QTc prolonged but \< 500 ms should be assessed by a cardiologist for eligibility;
• Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; Classes III-IV cardiac insufficiency according to the New York Heart Association (NYHA) Classification, or left ventricular ejection fraction (LVEF) \< 50% indicated in cardiac Doppler ultrasound;
• Allergy to any study drug or excipients;
• Active viral hepatitis requiring treatment as determined by the Investigators:
• Chronic hepatitis B, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients with positive test for Hepatitis B surface antigen or core antibody);
• Positive for Hepatitis C virus (HCV) ribonucleic acid (RNA) test (HCV RNA test only for patients with positive HCV antibodies);
• Any present active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or long-term heavy use of hormones or other immunomodulators, or other conditions assessed by the Investigator as having an impact on study treatment;
• Active infection;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (3)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210001, China

Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Nanjing Tumor Hospital

Nantong, Jiangsu, 226002, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Hongqian Guo, PhD

CONTACT

+86-13605171690; dr.ghq@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Urology

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 21, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)