Current partner codePEPTIDESDE
NCT05701007·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

1,083

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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?

Interventions

Treatment arms and agents.

DRUG

abiraterone

mCRPC

DRUG

enzalutamide

mCRPC

DRUG

docetaxel

mCRPC

DRUG

apalutamide

mCRPC

DRUG

cabazitaxel

mCRPC

DRUG

Radium-223

mCRPC

DRUG

Lutetium-177

mCRPC

DRUG

degarelix

mCSPC

DRUG

goserelin

mCSPC

DRUG

leuprorelin

mCSPC

DRUG

triptorelin

mCSPC

Timeline

From registration to results.

  1. First posted

    Jan 26, 2023

  2. Study start

    Feb 13, 2023

  3. Primary completion

    Apr 10, 2024

  4. Study completion

    Apr 10, 2024

  5. Results posted

    Jan 29, 2026

  6. Registry updated

    Jan 29, 2026

Outcomes

What the study measures.

Primary outcomes

Body Mass Index (BMI)

Time frame · 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months

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).

Prostate-Specific Antigen (PSA)

Time frame · 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months

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).

Alkaline Phosphatase (P-AFOS)

Time frame · 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months

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).

Length of Follow-up

Time frame · 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

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).

Number of Participants With de Novo Metastasis

Time frame · Within 2 months from index date; retrospective available data evaluated in this study for approximately 14 months

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).

Number of Participants Who Received Treatment for mCRPC and mCSPC

Time frame · 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 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).

Number of Participants Diagnosed With mCSPC Who Progressed to mCRPC

Time frame · 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 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).

Number of Participants With Orchiectomy

Time frame · 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 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).

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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 locations

1 registered sites.

Finland. Showing up to 24 locations stored in the fast local snapshot.

Pfizer

Helsinki, Finland

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Put the record in context.

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