Clinical trial NCT05701007: Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Official title: Real World Evidence Study on Metastatic Prostate Cancer Patient Characteristics, Treatment Patterns and Outcomes in the Pirkanmaa Hospital District in Finland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Keywords: mCRPC
metastatic prostate cancer
registry study
RWE
real world evidence
Finland
Metastasis
Prostatic Neoplasms
Prostate cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with advanced/metastatic prostate cancer and medical records available in the Hospital District of Pirkanmaa, Finland registry

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?


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.

Primary outcomes:
measure: Characteristics of Metastatic Cancer Patients
timeFrame: up to 12 years
measure: Number of treatments received for metastatic prostate cancer
timeFrame: up to 12 years
measure: Overall Survival (OS)
timeFrame: up to 12 years
measure: Time to next treatment (TTNT)
timeFrame: up to 12 years
Secondary outcomes:
measure: Time of disease progression from castration sensitive to castration resistant
timeFrame: up to 12 years
measure: Identify factors associated with disease progression to castration resistant
timeFrame: Up to 12 years
measure: The number of patients per treatment type
timeFrame: up to 12 years
measure: Incidence of metastatic prostate cancer (mPC)
timeFrame: Up to 12 years
measure: Incidence of metastatic castration sensitive prostate cancer (mCSPC)
timeFrame: up to 12 years
measure: Incidence of metastatic castration resistant prostate cancer (mCRPC)
timeFrame: up to 12 years
measure: Health Care resource utilization (HCRU): number of outpatient clinic visits, hospitalization and hospital inpatient days
timeFrame: up to 12 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: