Clinical trial NCT04122976: 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
Official title: Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 805
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with a diagnosis of nmCRPC will be enrolled after the decision for treatment with darolutamide has been made by the investigator.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 30 days after last dose of darolutamide within the patient's observation period
measure: 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
measure: Action taken related to darolutamide treatment
timeFrame: Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary outcomes:
measure: Subject's demographics
timeFrame: Up to 7 years
measure: Subject's characteristics
timeFrame: Up to 7 years
measure: Co-morbidities
timeFrame: Up to 7 years
measure: Disease course and progression (including performance status)
timeFrame: Up to 7 years
measure: Concomitant medication/treatment (including opioids)
timeFrame: Up to 7 years
measure: Dosage and dose modification of darolutamide
timeFrame: Up to 7 years
measure: Reasons for ending treatment and/or observation/follow-up
timeFrame: Up to 7 years
measure: Metastasis-Free Survival (MFS)
timeFrame: Up to 7 years
measure: Time to Symptomatic Skeletal Event (TSSE)
timeFrame: Up to 7 years
measure: Time to Prostate-Specific Antigen (PSA) progression
timeFrame: Up to 7 years
measure: Survival rate
timeFrame: Up to 7 years
measure: Duration of darolutamide therapy
timeFrame: Up to 7 years
measure: Imaging exams used to define tumor status
timeFrame: Up to 7 years
measure: Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
timeFrame: Up to 7 years
measure: Prior and post - darolutamide treatments for prostate cancer
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Tucson
country: United States
facility: Arizona Institute of Urology
state: Arizona
city: San Diego
country: United States
facility: Genesis Comprehensive Prostate Cancer Center
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Englewood
country: United States
facility: New Jersey Urology
state: New Jersey
city: Beacon
country: United States
facility: Beacon Cancer Care
state: New York
city: N. New Hyde Park
country: United States
facility: Integrated Medical Professionals, PLLC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professional Urology
state: New York
city: Durham
country: United States
facility: Dukes Cancer Intitute Center for Prostate and Urologic Cancers
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of NC
state: North Carolina
city: Springfield
country: United States
facility: Oregon Urology Institutue
state: Oregon
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Multiple Locations
country: Argentina
facility: Many Locations
city: Multiple Locations
country: Austria
facility: Many Locations
city: Multiple Locations
country: Belgium
facility: Many Locations
city: Multiple Locations
country: Brazil
facility: Many Locations
city: Multiple Locations
country: Canada
facility: Many Locations
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Colombia
facility: Many Locations
city: Multiple Locations
country: Denmark
facility: Many Locations
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: Greece
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Japan
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
References: