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

Study Overview
=================
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.

Official Title
-----------------
Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Darolutamide(Nubeqa, BAY1841788)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men with nmCRPC<br>Men with nmCRPC for whom a decision to treat with darolutamide has been made before enrollment, and who have signed informed consent, will be eligible for the study. | Drug: Darolutamide(Nubeqa, BAY1841788)<br>* The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment-emergent adverse events (TEAEs) | Including severity, seriousness and outcome. | 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) |  | Up to 30 days after last dose of darolutamide within the patient's observation period | 
| Action taken related to darolutamide treatment | Dose modifications and time periods | Up to 30 days after last dose of darolutamide within the patient's observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's demographics |  | Up to 7 years | 
| Subject's characteristics |  | Up to 7 years | 
| Co-morbidities |  | Up to 7 years | 
| Disease course and progression (including performance status) |  | Up to 7 years | 
| Concomitant medication/treatment (including opioids) |  | Up to 7 years | 
| Dosage and dose modification of darolutamide |  | Up to 7 years | 
| Reasons for ending treatment and/or observation/follow-up |  | Up to 7 years | 
| Metastasis-Free Survival (MFS) |  | Up to 7 years | 
| Time to Symptomatic Skeletal Event (TSSE) |  | Up to 7 years | 
| Time to Prostate-Specific Antigen (PSA) progression |  | Up to 7 years | 
| Survival rate |  | Up to 7 years | 
| Duration of darolutamide therapy |  | Up to 7 years | 
| Imaging exams used to define tumor status |  | Up to 7 years | 
| Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding) |  | Up to 7 years | 
| Prior and post - darolutamide treatments for prostate cancer |  | Up to 7 years |