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

April 23, 2024 updated by: Pfizer

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

April 10, 2024

Study Completion (Actual)

April 10, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3441057
  • PrCa-RWD (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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