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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701007

Collaborator

(none)

15,000

Enrollment

10.2

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration Sensitive Prostate Cancer (mCSPC) Metastatic Castration Resistant Prostate Cancer (mCRPC)	Drug: abiraterone Drug: enzalutamide Drug: docetaxel Drug: apalutamide Drug: cabazitaxel Drug: Radium-223 Drug: Lutetium-177 Drug: degarelix Drug: goserelin Drug: leuprorelin Drug: triptorelin

Study Design

Study Type:

Observational

Anticipated Enrollment :

15000 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 23, 2023

Anticipated Primary Completion Date :

Apr 28, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients diagnosed with metastatic castration sensitive prostate cancer (mCSPC)	Drug: degarelix mCSPC Drug: goserelin mCSPC Drug: leuprorelin mCSPC Drug: triptorelin mCSPC
Patients diagnosed with metastatic castration resistant prostate cancer (mCRPC)	Drug: abiraterone mCRPC Drug: enzalutamide mCRPC Drug: docetaxel mCRPC Drug: apalutamide mCRPC Drug: cabazitaxel mCRPC Drug: Radium-223 mCRPC Drug: Lutetium-177 mCRPC

Arm

Intervention/Treatment

Patients diagnosed with metastatic castration sensitive prostate cancer (mCSPC)

Drug: degarelix

mCSPC

Drug: goserelin

mCSPC

Drug: leuprorelin

mCSPC

Drug: triptorelin

mCSPC

Patients diagnosed with metastatic castration resistant prostate cancer (mCRPC)

Drug: abiraterone

mCRPC

Drug: enzalutamide

mCRPC

Drug: docetaxel

mCRPC

Drug: apalutamide

mCRPC

Drug: cabazitaxel

mCRPC

Drug: Radium-223

mCRPC

Drug: Lutetium-177

mCRPC

Outcome Measures

Primary Outcome Measures

Characteristics of Metastatic Cancer Patients [up to 12 years]
Demographical and clinical variables of patients will be summarized
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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.