do_not_disturb_altRecruitment Complete
Prostate cancer
Bayer Identifier:
20590
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study in which non-metastatic castration-resistant prostate cancer (nmCRPC) patients for whom a decision to treat with darolutamide has been made before enrollment are observed and certain outcomes are described
Trial purpose
The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
805Trial Dates
January 2020 - October 2026Phase
N/ACould I Receive a placebo
NoProducts
Nubeqa (Darolutamide, BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many Locations | Many Locations, Argentina |
Active, not recruiting | Many Locations | Many Locations, Austria |
Withdrawn | Many Locations | Many Locations, Australia |
Active, not recruiting | Many Locations | Many Locations, Belgium |
Active, not recruiting | Many Locations | Many Locations, Brazil |
Active, not recruiting | Many Locations | Many Locations, Canada |
Active, not recruiting | Many Locations | Many Locations, China |
Active, not recruiting | Many Locations | Many Locations, Colombia |
Active, not recruiting | Many Locations | Many Locations, Germany |
Active, not recruiting | Many Locations | Many Locations, Denmark |
Active, not recruiting | Many Locations | Many Locations, Spain |
Withdrawn | Many Locations | Many Locations, Finland |
Active, not recruiting | Many Locations | Many Locations, France |
Withdrawn | Many Locations | Many Locations, United Kingdom |
Active, not recruiting | Many Locations | Many Locations, Greece |
Withdrawn | Many Locations | Many Locations, Hong Kong |
Withdrawn | Many Locations | Many Locations, Ireland |
Withdrawn | Many Locations | Many Locations, India |
Active, not recruiting | Many Locations | Many Locations, Italy |
Active, not recruiting | Many Locations | Many Locations, Japan |
Withdrawn | Many Locations | Many Locations, Mexico |
Withdrawn | Many Locations | Many Locations, Netherlands |
Withdrawn | Many Locations | Many Locations, Norway |
Active, not recruiting | Many Locations | Many Locations, Russia |
Withdrawn | Many Locations | Many Locations, Sweden |
Withdrawn | Many Locations | Many Locations, Slovakia |
Withdrawn | Many Locations | Many Locations, Turkey |
Active, not recruiting | Many Locations | Many Locations, Taiwan |
Recruiting | Dukes Cancer Intitute Center for Prostate and Urologic Cancers | Durham, 27710, United States |
Recruiting | Arizona Institute of Urology | Tucson, 85704, United States |
Recruiting | Associated Medical Professional Urology | Syracuse, 13210, United States |
Recruiting | University of Washington | Seattle, 98101, United States |
Recruiting | Urology San Antonio | San Antonio, 78229, United States |
Recruiting | Urology Centers of Alabama | Homewood, 35209, United States |
Recruiting | First Urology, PSC | Jeffersonville, 47130, United States |
Recruiting | Keystone Urology Specialists | Lancaster, 17601, United States |
Recruiting | Wichita Urology Group | Wichita, 67206, United States |
Recruiting | Genesis Comprehensive Prostate Cancer Center | San Diego, 92123, United States |
Recruiting | New Jersey Urology | Englewood, 07631, United States |
Recruiting | Manatee Medical Research Institute | Bradenton, 34205, United States |
Recruiting | Associated Urologists of NC | Raleigh, 27612, United States |
Recruiting | Oregon Urology Institutue | Springfield, 01106, United States |
Recruiting | Vanderbilt University Medical Center | Nashville, 37203, United States |
Recruiting | Baylor Scott & White Medical Center - Temple | Temple, 76508, United States |
Recruiting | Urology of Virginia | Virginia Beach, 23462, United States |
Completed | Integrated Medical Professionals, PLLC | North New Hyde Park, 11042, United States |
Recruiting | Advanced Urology Institute | Daytona Beach, 32114, United States |
Recruiting | MultiCare Institute for Research & Innovation | Tacoma, 98405, United States |
Recruiting | Premier Medical Group of the Hudson Valley, PC | Poughkeepsie, 12603, United States |
Recruiting | Southcoast Centers for Cancer Care | Fairhaven, 02719, United States |
Recruiting | The Urology Center of Colorado | Denver, 80211, United States |
Recruiting | Beacon Cancer Care | Beacon, 83814, United States |
Recruiting | Research by Design, LLC | Chicago, 60643, United States |
Primary Outcome
- Occurrence of treatment-emergent adverse events (TEAEs)Including severity, seriousness and outcome.date_rangeTime Frame:Up to 30 days after last dose of darolutamide within the patient's observation period
- Reasonable causal relationship between darolutamide and an adverse event (AE)date_rangeTime Frame:Up to 30 days after last dose of darolutamide within the patient's observation period
- Action taken related to darolutamide treatmentDose modifications and time periodsdate_rangeTime Frame:Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary Outcome
- Subject's demographicsdate_rangeTime Frame:Up to 7 years
- Subject's characteristicsdate_rangeTime Frame:Up to 7 years
- Co-morbiditiesdate_rangeTime Frame:Up to 7 years
- Disease course and progression (including performance status)date_rangeTime Frame:Up to 7 years
- Concomitant medication/treatment (including opioids)date_rangeTime Frame:Up to 7 years
- Dosage and dose modification of darolutamidedate_rangeTime Frame:Up to 7 years
- Reasons for ending treatment and/or observation/follow-update_rangeTime Frame:Up to 7 years
- Metastasis-Free Survival (MFS)date_rangeTime Frame:Up to 7 years
- Time to Symptomatic Skeletal Event (TSSE)date_rangeTime Frame:Up to 7 years
- Time to Prostate-Specific Antigen (PSA) progressiondate_rangeTime Frame:Up to 7 years
- Survival ratedate_rangeTime Frame:Up to 7 years
- Duration of darolutamide therapydate_rangeTime Frame:Up to 7 years
- Imaging exams used to define tumor statusdate_rangeTime Frame:Up to 7 years
- Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)date_rangeTime Frame:Up to 7 years
- Prior and post - darolutamide treatments for prostate cancerdate_rangeTime Frame:Up to 7 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A