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

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

• Study Type: Observational
• Enrollment (Actual): 1083

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Pfizer

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

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
Body Mass Index (BMI)	BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass. It is widely used as a general indicator of whether a participant has a healthy body weight for their height. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months
Prostate-Specific Antigen (PSA)	PSA is a protein produced by the prostate gland, and the PSA test measures its levels in the blood. It is primarily used to screen for prostate cancer and monitor participants after treatment. Elevated PSA levels may indicate prostate cancer or other prostate abnormalities. Common prostate abnormalities include benign prostatic hyperplasia, prostatitis, prostate cancer. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months
Alkaline Phosphatase (P-AFOS)	Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months
Length of Follow-up	Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants With de Novo Metastasis	The new metastasis was defined based on the prostate cancer diagnosis dates within 2 months from the index date. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to metastatic castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered new CRPC).	Within 2 months from index date; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Who Received Treatment for mCRPC and mCSPC	Number of participants who received treatment for mCRPC and mCSPC were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Diagnosed With mCSPC Who Progressed to mCRPC	Number of participants initially diagnosed With mCSPC who progressed into mCRPC were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants With Orchiectomy	Number of participants with orchiectomy done were reported in this outcome measure. Orchiectomy is a surgical procedure in which one or both testicles are removed. It is commonly performed to treat or prevent prostate cancer from spreading. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Closest record any time from index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Undergone Palliative Radiology	Number of participants with palliative radiology done were reported in this outcome measure. This is a treatment designed to alleviate symptoms caused by advanced cancer, rather than cure the disease. It is commonly used to reduce tumor size or provide relief from pain, bleeding, or obstructions, ultimately enhancing the participant's quality of life. It is especially beneficial for participants with cancers that cannot be cured, offering relief from distressing symptoms such as tumor compression on organs or bones, as well as severe pain. Palliative radiology is analyzed based on procedure code (WF049). Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants With Symptomatic Skeletal-Related Event (SSRE)	SSRE was defined as bone instability related to the treatment of advanced prostate cancer or due to the spread of prostate cancer to the bone (metastases). Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants With Osteoporosis	Number of participants with osteoporosis were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Who Were on Bone Medication	Number of participants who were on bone medication (denosumab, zoledronic acid) were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Who Were on Opioids	Number of participants who were on opioids (morphine, oxycodone, fentanyl, methadone, hydromorphone) were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Classified Per Charlson Comorbidity Index (CCI) Scores	CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity. CCI was reported based on comorbidities reported 5 years before the index (index date included). Participants with grade 4 or more than 4 were combined and presented to avoid risk of re-identification of participants. Only those categories are reported which had at least 1 participant data in any of the reporting group. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Up to 5 years before the index date (index date included); retrospective available data evaluated in this study for approximately 14 months
Number of Participants Classified Per Gleason Score	Gleason score is used to grade tumors based upon its microscopic appearance. Gleason scores range from 1 (low-grade cancer) to 10 (high-grade cancer). Low grade prostate cancer grows more slowly than high-grade cancer and is less likely to spread (metastasize). Scores from 3-5 have been combined to avoid risk of re-identification of participants. Only those categories are reported which had at least 1 participant data in any of the reporting group. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Closest record any time from index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approx.14 months
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: T	T categories: T1, T2, T3, T4; In this, T describes the size of the tumor and any spread of cancer into nearby tissue. Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC). Higher numbers indicate greater the tumor size.	Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: N	N categories: N0, N1, N2, NX. N describes spread of cancer to nearby lymph nodes. Numbers after the N (such as N0, N1, N2, NX) describe tumor size and/or amount of spread into nearby structures. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC). Higher numbers indicate greater the tumor size and spread into nearby lymph nodes.	Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: M	M categories: M0, M1. M describes metastasis (spread of cancer to other parts of the body). Numbers after the M (such as M0, M1) describe tumor size and/or amount of spread into nearby structures. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC). Higher numbers indicate greater the tumor size and spread into nearby body parts.	Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Based on Eastern Cooperative Oncology Group Performance Status (ECOG PS)	ECOG PS is a scale to assess a participant's disease status. 0 = fully active, able to carry out all pre-disease performance without restriction; 1 = restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = ambulatory and capable of all self-care, unable to carry out any work activities. up and about > 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = completely disabled, confined to bed or chair; 5 = dead. Only those categories are reported which had at least 1 participant data in any of the reporting group. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
Number of Participants According to Treatment Per Treatment Line for mPC: mCSPC Participants	Number of participants according to treatment per treatment line (first, second, third and fourth line) for mPC for mCSPC participants were reported in this outcome measure. Palliative care was analyzed based on International Classification of Diseases- 10th revision (ICD-10) code Z51.5. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants According to Treatment Per Treatment Line for mPC: mCRPC Participants	Number of participants according to treatment per treatment line (first, second, third and, fourth, and fifth line) for mPC for mCRPC participants were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Overall Survival (OS)	OS was defined as time from index until death (event) or end of study identification 31-Dec-2022 (censoring event). Kaplan-Meier method was used for analysis. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Time to Next Treatment (TTNT)	TTNT was defined as time from initiation of the current treatment line until the initiation of the next treatment line (event), death (event), or end of study identification 31-Dec-2022 (censoring event). Data for first, second, third, fourth and fifth line treatment line was provided in this outcome measure. Kaplan-Meier method was used for analysis.	From initiation of current treatment line until initiation of next treatment line, death censoring event, whichever occurred first, maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Time to Disease Progression	Time to disease progression was defined as time from mCSPC index until mCRPC index (event), death (competing event) or end of study identification period (31-December-2022; censoring event). Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	From mCSPC index until mCRPC index, death or censoring event, whichever occurred first, maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Participants Per Factors Associated With Disease Progression to Castration Resistant	Factors associated with disease progression to castration resistant included age, CCI, De nova mPC and Gleason score. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	From mCSPC index until mCRPC index, death or censoring event, whichever occurred first, maximum up to 24 months; retrospective available data evaluated in this study for approximately 14 months
Annual Incidence of mPC, mCSPC and mCRPC	Incidence was calculated by dividing the number of incident participants each year (2014-2022) by the yearly size of background population in PHD. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC). In this outcome measure for arms mCSPC and mCRPC only those participants are reported who were classified or recorded as mCSPC and mCRPC in specified year. All participants reported under Overall Cohort mPC might not have been recognized/classified/recorded as mCSPC and mCRPC for the specified year, hence sum of participants reported against mCSPC and mCRPC might be less than the participants reported for mPC for that specified year.	From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Events Per Participant Year for Outpatient Clinic Contacts, Hospitalization Contacts	Number of events per participant year for outpatient clinic contacts, hospitalization contacts were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation [1st control usually at 3 months], considered de novo CRPC).	From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx. 9 years; retrospective available data evaluated in this study for approximately 14 months
Number of Days Per Participant Year for Hospital Inpatient Days	Number of days per participant year for hospital inpatient days were reported in this outcome measure.	From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx. 9 years; retrospective available data evaluated in this study for approximately 14 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; mCRPC; Finland; Prostatic Neoplasms; Metastasis; metastatic prostate cancer; real world evidence; registry study; RWE
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Neoplasm Metastasis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Gonadotropin-Releasing Hormone; Docetaxel; Leuprolide; Goserelin; Triptorelin Pamoate; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; abiraterone; enzalutamide; cabazitaxel; Radium-223; Lutetium-177; apalutamide
• 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