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Metastatic Hormone-sensitive Prostate CancerPhase 2ARASECNCT05059236

A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

A Phase 2 study testing Darolutamide (BAY1841788, Nubeqa) and ADT in people with Metastatic Hormone-sensitive Prostate Cancer, run by Bayer at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Darolutamide (BAY1841788, Nubeqa) and ADT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
31 sitesUnited States
Study dates
4 Nov 2021to 15 Jun 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of prostate. Participants may have begun androgen-deprivation therapy (up to 120 days prior to enrollment). Note: Relugolix is not permitted as ADT in this study.
  • Metastatic disease and will be stratified by presence of high volume or low volume disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  • Adequate bone marrow, liver and renal function within 4 weeks of enrollment
  • At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment
  • Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:
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  • Therapy was discontinued ≥ 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following:
  • PSA < 0.1 ng/mL after prostatectomy plus hormonal therapy
  • PSA < 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy
  • Therapy lasted no more than 24 months
  • Prior palliative radiotherapy allowed for participants, if commenced within 30 days before starting androgen deprivation.
  • Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy ≤ 28 days before medical castration to prevent flare.

Who cannot join

  • PSA met criteria for PSA progression
  • History of malignancy in the past 5 years, with the exception of basal cell and squamous cell carcinoma of the skin.
  • Had any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities
  • Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
  • Known brain/ leptomeningeal metastases
  • An active viral hepatitis (defined as Hepatitis B surface antigen [HBsAg] reactive or detectable [qualitative] HBV DNA defined as HCV Ribonucleic Acid [RNA] [qualitative] is detected), known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment
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  • Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
  • A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
  • Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his compliance with study procedures or may interfere with the participant's participation in the study or evaluation of the study results.
  • Prior hormone therapy in the metastatic setting
  • Prior chemotherapy in the adjuvant or neoadjuvant setting
  • Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 days before the start of darolutamide or 5 half-lives of the drug, whichever is longer)
  • Any Prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer
  • Previous (within 28 days before the start of darolutamide or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
  • Contraindication to both CT and MRI contrast agent
  • Hypersensitivity to any of the study treatments, study treatment classes, or excipients in the formulation of the study treatments
  • Inability to swallow oral medications

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • New Mexico Cancer Center - Albuquerque

    Albuquerque, New Mexico, 87109

  • Lieutenant Colonel Charles S. Kettles VA Medical Center - Oncology

    Ann Arbor, Michigan, 48105

  • Brigham and Women's Hospital (BWH) - Surgery Urology

    Atlanta, Georgia, 30318

  • Piedmont Cancer Institute - Atlanta

    Atlanta, Georgia, 30318

  • MidLantic Urology - Bala Cynwyd

    Bala-Cynwyd, Pennsylvania, 19004

  • UM Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Northwestern Medicine - Urology

    Chicago, Illinois, 60611

  • Northwestern University's Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Urology Group - Norwood Surgery Center

    Cincinnati, Ohio, 45212

  • New Jersey Urology - Clifton

    Clifton, New Jersey, 07013

  • Barbara Ann Karmanos Cancer Institute - Detroit Headquarters

    Detroit, Michigan, 48201

  • Inova Schar Cancer Institute (vendor)

    Fairfax, Virginia, 22031

  • Columbus Prostate Cancer Center / Radiation Oncology Clinic

    Gahanna, Ohio, 43230

  • Urology Centers of Alabama, PC - Homewood

    Homewood, Alabama, 35209

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • AMR - Kansas City

    Kansas City, Missouri, 64132

  • Tower Urology

    Los Angeles, California, 90048

  • Carolina Urological Research Center

    Myrtle Beach, South Carolina, 29579

  • Urology Associates, PC - Nashville

    Nashville, Tennessee, 37209

  • Mount Sinai Doctors - Faculty Practice

    New York, New York, 10029

  • Mount Sinai Faculty Practice Associates

    New York, New York, 10029

  • GU Research Network, LLC - Oncology radiology

    Omaha, Nebraska, 68130

  • XCancer Omaha

    Omaha, Nebraska, 68130

  • UCI Health Center for Urological Care

    Orange, California, 92868

  • UC San Diego Health - Moores Cancer Center

    San Diego, California, 92037

  • Providence Saint John's Cancer Institute

    Santa Monica, California, 90404

  • Spokane Urology PS

    Spokane, Washington, 99202

  • Associated Medical Professionals of NY Syracuse

    Syracuse, New York, 13210

  • Michigan Institute of Urology - Troy - Town Center Building

    Troy, Michigan, 48084

  • Arizona Urology Specialists - Tucson - W Orange Grove

    Tucson, Arizona, 85741

  • New Jersey Urology - Voorhees

    Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm

The purpose of the study is to assess if the addition of darolutamide to ADT compared with ADT alone would result in superior clinical efficacy in participants with metastatic hormone-sensitive prostate cancer (mHSPC) by progression-free survival.

The researchers want to learn how long it takes for the cancer to get worse (also known as "progression-free survival") by either increasing symptoms, new metastases, PSA rise or death. All participants will be on treatment and take darolutamide with ADT until their cancer spreads, they have a medical problem, or they leave the study. The results will then be compared with patients' results from another study who received ADT alone (CHAARTED).

Read more

This study will also assess safety by gathering adverse event information throughout the duration of the study. An adverse event is any medical problem, related or not to study treatment that a participant has during a study.

The study drug, is already available for doctors to prescribe to patients with prostate cancer, including those with metastatic disease as well as those whose cancer has not yet spread to other parts of the body.

The study drug, darolutamide, works by blocking a protein called a receptor from attaching to a hormone called androgen that is found in men. This protein can also be found in prostate cancer cells. ADT is a treatment that doctors are currently able to prescribe to patients with mHSPC. ADT is used to lower the amount of the androgen hormone.

Darolutamide is approved for use with ADT, with or without docetaxel, in patients with mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease.

Being tested
Darolutamide (BAY1841788, Nubeqa), ADT
Keywords
Metastatic hormone-sensitive prostate cancer (mHSPC), Prostate Cancer, Darolutamide, Nubeqa
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Darolutamide (BAY1841788, Nubeqa)Drug

    300 mg per tablet, oral administration with food

  • ADTOther

    LHRH agonist/antagonist or orchiectomy

Study groups in NCT05059236
Study groupRoleWhat they receive
Darolutamide+ADTExperimentalParticipants will receive darolutamide plus ADT in the ARASEC treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach
Receives: Drug: Darolutamide (BAY1841788, Nubeqa); Other: ADT

What is being measured

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

  1. Progression Free Survival (PFS)

    Time interval from enrollment to PSA progression, clinical progression or death, whichever occurs first. PSA progression is defined as when the PSA demonstrates an increase that is more than 50% of nadir, taking as reference the lowest recorded PSA level since starting androgen deprivation therapy (ADT). Clinical progression is defined as increasing symptomatic bone metastases, radiographic progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases, or clinical deterioration due to cancer per investigator's opinion.

    Measured: From start of treatment to the date when approximately 161 PFS events were observed across the ARASEC cohort and the matched controls, approximately 40 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Time from the date of enrollment until death resulting from any cause or the date last known alive.

    Measured: From start of treatment to the date when approximately 161 PFS events were observed across the ARASEC cohort and the matched controls, approximately 40 months.

  2. Radiographic Progression-free Survival (rPFS)

    Time from enrollment to investigator-assessed radiographic progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v. 1.1) for soft tissue metastases and PCWG3 criteria for bone metastases or death, whichever occurs first.

    Measured: From start of treatment to the date when approximately 161 PFS events were observed across the ARASEC cohort and the matched controls, approximately 40 months.

  3. Time to Castration-resistant Prostate Cancer (CRPC)

    Time from enrollment until documented clinical or PSA progression with a testosterone level of less than 50 ng per deciliter or documented medical castration or surgical castration.

    Measured: From start of treatment to the date when approximately 161 PFS events were observed across the ARASEC cohort and the matched controls, approximately 40 months.

  4. Undetectable PSA Response Rate

    PSA level of less than 0.2 ng per milliliter on two consecutive measurements at least 4 weeks apart.

    Measured: At 6 months after study drug first administration.

  5. Number of Participants With Adverse Events

    Adverse Events (AEs) were assessed by National Cancer Institute-Common Terminology Criteria (NCI CTCAE) v. 5.0. Treatment-emergent AE (TEAEs) is defined as any event any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug.

    Measured: From start of study drug administration until 30 days after the last administration.

Timeline

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

  1. First posted28 Sep 2021
  2. Study start4 Nov 2021
  3. Primary completion30 May 2025
  4. Study completion15 Jun 2026

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
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05059236
Sponsor's protocol ID
21516
Acronym
ARASEC
Status last verified
Aug 2026
First submitted
17 Sep 2021
Last updated
15 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

  • McKay RR, Ross AE, Preston MA, Gregg JR, Salami SS, Littleton N, Constantinovici N, Srinivasan S, Verholen F, Shore ND. Darolutamide plus androgen-deprivation therapy: propensity score matching of ARASEC and historic clinical trial patients. Future Oncol. 2025 May;21(11):1365-1375. doi: 10.1080/14796694.2025.2482360. Epub 2025 Apr 1.

    PubMed 40165634

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide (BAY1841788, Nubeqa) and ADT in people with Metastatic Hormone-sensitive Prostate Cancer, run by Bayer at 31 sites in United States.

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 12 inclusion and 17 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. 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?

Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From start of treatment to the date when approximately 161 PFS events were observed across the ARASEC cohort and the matched controls, approximately 40 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 NCT05059236, which also lists 1 linked publication.

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 15 Sep 2026.

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