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

NCT ID: NCT05778097

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apalutamide+ADT

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

Group Type: EXPERIMENTAL

Apalutamide 60mg Tab

Intervention Type: DRUG

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

Androgen deprivation therapy(ADT)

Intervention Type: 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.

Interventions

Apalutamide 60mg Tab

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;

2. Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;

3. PSA < 0.1 ng/ml within 8 weeks after surgery;

4. Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;

5. ECOG score at 0-1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale;

6. 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)：

1. Neutrophil count (NE) ≥1.5×109/L;

2. Hemoglobin (HGB) ≥ 90 g/L;

3. 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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1. Creatinine clearance ≥ 30 mL/min;

2. Total bilirubin (TBIL) ≤ 1.5× ULN;

3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;

7. Ability to provide written informed consent form (ICF) and ability to understand and agree to adhere to study requirements and schedule of assessments;

8. Patients of childbearing potential must be willing to use highly effective contraception during the study and for 12 weeks after the last dose of treatment.

Exclusion Criteria

1. Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;

2. Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;

3. Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;

4. Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);

5. Any major surgery (other than radical resection) requiring general anesthesia within 28 days prior to the first dose of the study;

6. 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);

7. 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;

8. Corrected QT interval (QTc) of heart rate > 500 ms; patients with QTc prolonged but < 500 ms should be assessed by a cardiologist for eligibility;

9. 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;

10. Allergy to any study drug or excipients;

11. Active viral hepatitis requiring treatment as determined by the Investigators:

1. 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);

2. Positive for Hepatitis C virus (HCV) ribonucleic acid (RNA) test (HCV RNA test only for patients with positive HCV antibodies);

12. 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;

13. Active infection;

14. History of interstitial lung disease or uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc.;

15. Known to have human immunodeficiency virus (HIV) infection;

16. History of epilepsy or conditions that may induce epilepsy

17. The presence of an underlying medical condition alcohol/drug abuse or dependence that is detrimental to the administration of the study drugs, or that may affect the interpretation of the results, or that places the patient at high risk of developing treatment complications;

18. Men who have sexual activity with women of childbearing potential, unless they:

Agree to use condom or spermicidal foam/gel/diaphragm/cream/suppository Agree not to donate sperm during the study and for at least 3 months after receiving the last dose of study drug No birth plan during the study or within 3 months after the last dose of study drug

19. Concurrent participation in another therapeutic clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

Chief physician of Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Nanjing Tumor Hospital

Nantong, Jiangsu, China

Countries

China

Central Contacts

Hongqian Guo, PhD

Role: CONTACT

dr.ghq@nju.edu.cn

+86-13605171690

Facility Contacts

Luwei Xu

Role: primary

Hongqian Guo, PhD

Role: primary

dr.ghq@nju.edu.cn

+86-13605171690

Shun Zhang, PhD

Role: backup

explorershun@126.com

+86-15050589789

Xiaolin Wang

Role: primary

Other Identifiers

IUNU-PC-115

Identifier Type: -

Identifier Source: org_study_id