Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Study Overview
=================
Brief Summary
-----------------
Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking. This study will address the following questions: What are the demographic and clinical characteristics of metastatic prostate cancer patients? How are metastatic prostate cancer patients currently treated and how effective are these treatments? How does the development of castration-resistance affect patient outcomes? What is the economic burden of metastatic prostate cancer?

Official Title
-----------------
Real World Evidence Study on Metastatic Prostate Cancer Patient Characteristics, Treatment Patterns and Outcomes in the Pirkanmaa Hospital District in Finland

Conditions
-----------------
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
-----------------
* Drug: abiraterone
* Drug: enzalutamide
* Drug: docetaxel
* Drug: apalutamide
* Drug: cabazitaxel
* Drug: Radium-223
* Drug: Lutetium-177
* Drug: degarelix
* Drug: goserelin
* Drug: leuprorelin
* Drug: triptorelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of prostate cancer between 1/1/2007 - 12/31/2022 Resident of Pirkanmaa at index date (diagnosis of mCSPC and/or mCRPC) Detection of metastatic prostate cancer Exclusion Criteria: Prevalent mCSPC and mCRPC patients (mCSPC or mCRPC diagnosis date before 1/1/2014 Patient has another cancer diagnosis or the patient has received chemotherapy other than docetaxel or cabazitaxel within 2 years of mPC diagnosis.

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 |
| --- | --- |
| Patients diagnosed with metastatic castration sensitive prostate cancer (mCSPC)<br> | Drug: degarelix<br>* mCSPC<br>Drug: goserelin<br>* mCSPC<br>Drug: leuprorelin<br>* mCSPC<br>Drug: triptorelin<br>* mCSPC<br>|
| Patients diagnosed with metastatic castration resistant prostate cancer (mCRPC)<br> | Drug: abiraterone<br>* mCRPC<br>Drug: enzalutamide<br>* mCRPC<br>Drug: docetaxel<br>* mCRPC<br>Drug: apalutamide<br>* mCRPC<br>Drug: cabazitaxel<br>* mCRPC<br>Drug: Radium-223<br>* mCRPC<br>Drug: Lutetium-177<br>* mCRPC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of Metastatic Cancer Patients | Demographical and clinical variables of patients will be summarized | up to 12 years | 
| Number of treatments received for metastatic prostate cancer |  | up to 12 years | 
| Overall Survival (OS) |  | up to 12 years | 
| Time to next treatment (TTNT) |  | up to 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of disease progression from castration sensitive to castration resistant |  | up to 12 years | 
| Identify factors associated with disease progression to castration resistant |  | Up to 12 years | 
| The number of patients per treatment type |  | up to 12 years | 
| Incidence of metastatic prostate cancer (mPC) |  | Up to 12 years | 
| Incidence of metastatic castration sensitive prostate cancer (mCSPC) |  | up to 12 years | 
| Incidence of metastatic castration resistant prostate cancer (mCRPC) |  | up to 12 years | 
| Health Care resource utilization (HCRU): number of outpatient clinic visits, hospitalization and hospital inpatient days |  | up to 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mCRPC, metastatic prostate cancer, registry study, RWE, real world evidence, Finland, Metastasis, Prostatic Neoplasms, Prostate cancer