Trial Title:
Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)
NCT ID:
NCT05778097
Condition:
Prostate Cancer
Biochemical Recurrence
High Risk
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Androgens
Conditions: Keywords:
prostate cancer biochemical recurrence
apalutamide
adjuvant treatment
post-radical prostatectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide 60mg Tab
Description:
Apalutamide 60Mg Tab (4 x 60 mg) once daily on days 1-28 of a 28-day cycle
Arm group label:
Apalutamide+ADT
Intervention type:
Drug
Intervention name:
Androgen deprivation therapy(ADT)
Description:
The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency
of administration) will be consistent with the prescribing information.
Arm group label:
Apalutamide+ADT
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.
Criteria for eligibility:
Criteria:
Key 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)：
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.
Key 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing First Hospital, Nanjing Medical University
Address:
City:
Nanjing
Zip:
210001
Country:
China
Contact:
Last name:
Luwei Xu
Facility:
Name:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Contact:
Last name:
Hongqian Guo, PhD
Phone:
+86-13605171690
Email:
dr.ghq@nju.edu.cn
Contact backup:
Last name:
Shun Zhang, PhD
Phone:
+86-15050589789
Email:
explorershun@126.com
Investigator:
Last name:
Hongqian Guo, PhD
Email:
Principal Investigator
Investigator:
Last name:
Xuefeng Qiu, PhD
Email:
Sub-Investigator
Facility:
Name:
Nanjing Tumor Hospital
Address:
City:
Nantong
Zip:
226002
Country:
China
Contact:
Last name:
Xiaolin Wang
Start date:
April 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Xian-Janssen Pharmaceutical Ltd.
Agency class:
Industry
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05778097
