A Phase 2 interventional study of Darolutamide (BAY1841788, Nubeqa) and ADT in Metastatic Hormone-sensitive Prostate Cancer, sponsored by Bayer. Completed at 31 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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).
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 223 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:
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:
Exclusion Criteria:
Participants 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
Drug: Darolutamide (BAY1841788, Nubeqa) · Other: ADT
300 mg per tablet, oral administration with food
LHRH agonist/antagonist or orchiectomy
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.
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
Overall Survival (OS)
Time from the date of enrollment until death resulting from any cause or the date last known alive.
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.
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.
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.
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.
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.
Undetectable PSA Response Rate
PSA level of less than 0.2 ng per milliliter on two consecutive measurements at least 4 weeks apart.
Time frame: At 6 months after study drug first administration.
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.
Time frame: From start of study drug administration until 30 days after the last administration.
Study was conducted between 04 Nov 2021 (first participant first visit) and 30 May 2025 (primary completion date).
| Milestone | ARASEC ME-FAS |
|---|---|
| Started | 223 |
| Included in the arasec m-fas | 160 |
| Completed | 125 |
| Not completed | 98 |
| Withdrew: Adverse event | 18 |
| Withdrew: Progression disease - clinical assessment | 20 |
| Withdrew: Progressive disease - radiological progression | 9 |
| Withdrew: Physician decision | 9 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 15 |
| Withdrew: Death | 3 |
| Withdrew: Psa progression | 13 |
| Withdrew: Confirmed psa progression | 1 |
| Withdrew: Drug interruption | 1 |
| Withdrew: Per investigator assessment, progression based on rising psa score | 1 |
| Withdrew: Psa progression, new bone metastasis, did not meet criteria for radiographic progression | 1 |
| Withdrew: Poor compliance, stopped taking medication for > 28 days | 1 |
| Withdrew: Progressive disease - psa progression | 1 |
| Withdrew: Psa and bone progression | 1 |
| Withdrew: Unconfirmed progressive disease | 1 |
| Withdrew: Not reported | 1 |
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.
| Months | ARASEC M-FAS | CHAARTED M-FAS |
|---|---|---|
| Progression Free Survival (PFS) | NA (NA to NA) | 14.3 (11.20 to 17.38) |
Time from the date of enrollment until death resulting from any cause or the date last known alive.
| Months | ARASEC M-FAS | CHAARTED M-FAS |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
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.
| Months | ARASEC M-FAS | CHAARTED M-FAS |
|---|---|---|
| Radiographic Progression-free Survival (rPFS) | NA (NA to NA) | 29.0 (20.34 to NA) |
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.
| Months | ARASEC M-FAS | CHAARTED M-FAS |
|---|---|---|
| Time to Castration-resistant Prostate Cancer (CRPC) | NA (NA to NA) | 14.3 (11.20 to 18.43) |
PSA level of less than 0.2 ng per milliliter on two consecutive measurements at least 4 weeks apart.
| Percentage of participants | ARASEC M-FAS | CHAARTED M-FAS |
|---|---|---|
| Undetectable PSA Response Rate | 58.7 (50.8 to 66.5) | 22.6 (15.8 to 29.4) |
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.
| Participants | ARASEC ME-FAS | ARASEC M-FAS |
|---|---|---|
| Number of Participants With Adverse Events | 214 | 155 |
Collected over Adverse events (AEs) were collected from the start of study drug administration until 30 days after the last study dose. AE reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to the cut-off date for the primary completion analysis on 30 MAY 2025, with an average median duration on treatment of 25.33 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| M-FAS | 22/160 (13.8%) | 39/160 (24.4%) | 137/160 (85.6%) |
| ME-FAS | 26/223 (11.7%) | 52/223 (23.3%) | 196/223 (87.9%) |
| Event | M-FAS | ME-FAS |
|---|---|---|
| FallInjury, poisoning and procedural complications | 2/160 | 4/223 |
| AnaemiaBlood and lymphatic system disorders | 2/160 | 3/223 |
| PneumoniaInfections and infestations | 2/160 | 3/223 |
| VertigoEar and labyrinth disorders | 2/160 | 2/223 |
| SepsisInfections and infestations | 2/160 | 2/223 |
| COVID-19Infections and infestations | 2/160 | 2/223 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/160 | 2/223 |
| Malignant ascitesGastrointestinal disorders | 1/160 | 2/223 |
| CholecystitisHepatobiliary disorders | 1/160 | 2/223 |
| SyncopeNervous system disorders | 1/160 | 2/223 |
| Event | M-FAS | ME-FAS |
|---|---|---|
| FatigueGeneral disorders and administration site conditions | 51/160 | 85/223 |
| Hot flushVascular disorders | 59/160 | 85/223 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 27/160 | 41/223 |
| AnaemiaBlood and lymphatic system disorders | 22/160 | 33/223 |
| Weight increasedInvestigations | 23/160 | 30/223 |
| DiarrhoeaGastrointestinal disorders | 19/160 | 23/223 |
| Back painMusculoskeletal and connective tissue disorders | 19/160 | 24/223 |
| FallInjury, poisoning and procedural complications | 13/160 | 26/223 |
| DizzinessNervous system disorders | 18/160 | 22/223 |
| InsomniaPsychiatric disorders | 18/160 | 19/223 |
| Age, Continuous(Years) | ARASEC ME-FAS |
|---|---|
| Mean | 72.0 ± 8.7 |
| Sex: Female, Male(Participants) | ARASEC ME-FAS |
|---|---|
| Female | 0 |
| Male | 223 |
| Ethnicity (NIH/OMB)(Participants) | ARASEC ME-FAS |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 199 |
| Unknown or Not Reported | 15 |
| Race/Ethnicity, Customized(Participants) | ARASEC ME-FAS |
|---|---|
| White | 181 |
| Black or African American | 29 |
| Asian | 3 |
| American Indian or Alaska Native | 4 |
| Not Reported | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
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