Trial Condition(s):
Prostate Cancer
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 (DAROL)
Bayer Identifier:
20590
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Men over the age of 18 years - Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required - No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation - Decision to initiate treatment with darolutamide was made as per investigator’s routine treatment practice prior to enrollment in the study - Signed informed consent - Life expectancy of ≥3 months - For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide
Exclusion Criteria
- Participation in an investigational program with interventions outside of routine clinical practice - Contraindications according to the local marketing authorization - Previous treatment with darolutamide (more than 3 days prior to enrollment) - Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Argentina | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Brazil | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Colombia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Denmark | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dukes Cancer Intitute Center for Prostate and Urologic Cancers Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arizona Institute of Urology Tucson, United States, 85704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Associated Medical Professional Urology Syracuse, United States, 13210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Washington Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology San Antonio San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology Centers of Alabama Homewood, United States, 35209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First Urology, PSC Jeffersonville, United States, 47130 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keystone Urology Specialists Lancaster, United States, 17601 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wichita Urology Group Wichita, United States, 67206 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Genesis Comprehensive Prostate Cancer Center San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations New Jersey Urology Englewood, United States, 07631 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manatee Medical Research Institute Bradenton, United States, 34205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Associated Urologists of NC Raleigh, United States, 27612 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oregon Urology Institutue Springfield, United States, 01106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical Center Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Baylor Scott & White Medical Center - Temple Temple, United States, 76508 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology of Virginia Virginia Beach, United States, 23462 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Integrated Medical Professionals, PLLC North New Hyde Park, United States, 11042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Advanced Urology Institute Daytona Beach, United States, 32114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MultiCare Institute for Research & Innovation Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Premier Medical Group of the Hudson Valley, PC Poughkeepsie, United States, 12603 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southcoast Centers for Cancer Care Fairhaven, United States, 02719 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Urology Center of Colorado Denver, United States, 80211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beacon Cancer Care Beacon, United States, 83814 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research by Design, LLC Chicago, United States, 60643 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Darolutamide Observational Study in non-metastatic castration-resistant prostate cancer patients
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Occurrence of treatment-emergent adverse events (TEAEs)Including severity, seriousness and outcome.Timeframe: 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)Timeframe: Up to 30 days after last dose of darolutamide within the patient's observation period
- Action taken related to darolutamide treatmentDose modifications and time periodsTimeframe: Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary Outcome
- Subject's demographicsTimeframe: Up to 7 years
- Subject's characteristicsTimeframe: Up to 7 years
- Co-morbiditiesTimeframe: Up to 7 years
- Disease course and progression (including performance status)Timeframe: Up to 7 years
- Concomitant medication/treatment (including opioids)Timeframe: Up to 7 years
- Dosage and dose modification of darolutamideTimeframe: Up to 7 years
- Reasons for ending treatment and/or observation/follow-upTimeframe: Up to 7 years
- Metastasis-Free Survival (MFS)Timeframe: Up to 7 years
- Time to Symptomatic Skeletal Event (TSSE)Timeframe: Up to 7 years
- Time to Prostate-Specific Antigen (PSA) progressionTimeframe: Up to 7 years
- Survival rateTimeframe: Up to 7 years
- Duration of darolutamide therapyTimeframe: Up to 7 years
- Imaging exams used to define tumor statusTimeframe: Up to 7 years
- Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)Timeframe: Up to 7 years
- Prior and post - darolutamide treatments for prostate cancerTimeframe: Up to 7 years
Additional Information
Not Available
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