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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05059236
Other study ID # 21516
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 4, 2021
Est. completion date June 22, 2026

Study information

Verified date February 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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, darolutamide, is already available for doctors to prescribe to patients with prostate cancer that has not yet spread to other parts of the body. It 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 223
Est. completion date June 22, 2026
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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: - 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. Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darolutamide (BAY1841788, Nubeqa)
300 mg per tablet, oral administration with food
Other:
ADT
LHRH agonist/antagonist or orchiectomy

Locations

Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States VA Ann Arbor Healthcare System Ann Arbor Michigan
United States Piedmont Atlanta Hospital Atlanta Georgia
United States Piedmont Healthcare Atlanta Georgia
United States MidLantic Urology Bala-Cynwyd Pennsylvania
United States University Of Maryland Baltimore Maryland
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Northwestern University's Feinberg School of Medicine Chicago Illinois
United States The Urology Group Cincinnati Ohio
United States New Jersey Urology - Clifton Clifton New Jersey
United States Barbara Ann Karmanos Cancer Institute - Detroit Detroit Michigan
United States Inova Schar Cancer Institute Fairfax Virginia
United States Central Ohio Urology Gahanna Ohio
United States Urology Centers of Alabama PC Homewood Alabama
United States Houston Methodist Research Institute Houston Texas
United States Alliance for Multispecialty Research LLC - Kansas City Kansas City Missouri
United States University of Cal. San Diego Moores Cancer Ctr. La Jolla California
United States Tower Urology Los Angeles California
United States Carolina Urological Research Center Myrtle Beach South Carolina
United States Urology Associates, PC / Nashville Nashville Tennessee
United States Mount Sinai Faculty Practice Associates New York New York
United States GU Research Network, LLC - Oncology radiology Omaha Nebraska
United States John Wayne Cancer Institute Santa Monica California
United States Spokane Urology PS Spokane Washington
United States Associated Medical Professionals of NY, PLLC Syracuse New York
United States Michigan Institute of Urology, PC Troy Michigan
United States Arizona Urology Specialists Tucson Arizona
United States New Jersey Urology, LLC Voorhees New Jersey
United States GU Research Network, LLC Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Approximately 12 months after end of enrollment
Secondary Overall survival (OS) Time from the date of enrollment until death resulting from any cause or the date last known alive Approximately 24 months after end of enrollment
Secondary 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 Approximately 24 months after end of enrollment
Secondary 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 Approximately 12 months after end of enrollment
Secondary Complete PSA response rate PSA level of less than 0.2 ng per milliliter on two consecutive measurements at least 4 weeks apart At 6 months after first administration
Secondary Number of participants with adverse events Adverse Events will be assessed by National Cancer Institute-Common Terminology Criteria (NCI CTCAE) v. 5.0 From the signing of the informed consent form (ICF) until 30 (+7) days after last administration, approximately 12 months
See also
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Completed NCT05381311 - Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
Active, not recruiting NCT00309985 - Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Phase 3
Completed NCT03532217 - Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer Phase 1
Completed NCT02799602 - ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer Phase 3
Not yet recruiting NCT06134271 - Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer Phase 2
Active, not recruiting NCT04934722 - Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension Phase 3
Recruiting NCT05901649 - A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
Withdrawn NCT03343977 - Toxicity & Pharmacokinetics of 2 & 3-weekly Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Phase 1/Phase 2
Active, not recruiting NCT04191096 - Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Phase 3
Active, not recruiting NCT03879122 - A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer Phase 2/Phase 3