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Prostate CancerPhase 2ARESNCT05778097

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

A Phase 2 study testing Apalutamide 60mg Tab and Androgen deprivation therapy(ADT) in people with Prostate Cancer and Biochemical Recurrence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer, Biochemical Recurrence, High Risk
What is being tested?
Apalutamide 60mg Tab and Androgen deprivation therapy(ADT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
3 sitesChina
Study dates
1 Apr 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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;
  • 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.

Who cannot join

  • 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);
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  • 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;
  • History of interstitial lung disease or uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc.;
  • Known to have human immunodeficiency virus (HIV) infection;
  • History of epilepsy or conditions that may induce epilepsy
  • 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;
  • 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
  • Concurrent participation in another therapeutic clinical study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hongqian Guo, PhD contact

+86-13605171690

dr.ghq@nju.edu.cn

China3 sites

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210001

    Luwei Xu

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Hongqian Guo, PhD, +86-13605171690, dr.ghq@nju.edu.cn

    Shun Zhang, PhD, +86-15050589789, explorershun@126.com

  • Nanjing Tumor Hospital

    Nantong, Jiangsu, 226002

    Xiaolin Wang

Other trials in China

About this study

Official title: 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)

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.

Being tested
Apalutamide 60mg Tab, Androgen deprivation therapy(ADT)
Keywords
prostate cancer biochemical recurrence, apalutamide, adjuvant treatment, post-radical prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apalutamide 60mg TabDrug

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

  • 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.

Study groups in NCT05778097
Study groupRoleWhat they receive
Apalutamide+ADTExperimentalApalutamide (240 mg once daily) in combination with ADT for 12 cycles (28 days of each cycle)
Receives: Drug: Apalutamide 60mg Tab; Drug: Androgen deprivation therapy(ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (7)

  1. 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.

    Measured: from initiation with apalutamide up to 36 months

  2. 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;

    Measured: 60 months

  3. 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);

    Measured: 60 months

  4. 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

    Measured: 24 months

  5. Two-year testosterone recovery rate

    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.

    Measured: 24 months

  6. Time to testosterone recovery

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

    Measured: From initiation of apalutamide plus ADT up to 36 months

  7. Number of Adverse Events Number of Adverse Events Number of Adverse Events Adverse events (AEs)

    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.

    Measured: From initiation of apalutamide plus ADT to 30 days after last dose of apalutamide

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05778097
Sponsor's protocol ID
IUNU-PC-115
Acronym
ARES
Status last verified
Mar 2023
First submitted
4 Mar 2023
Last updated
21 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide 60mg Tab and Androgen deprivation therapy(ADT) in people with Prostate Cancer and Biochemical Recurrence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongqian Guo, PhD (+86-13605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two-year biochemical progression-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05778097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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