Trial · Observational
CompletedPhase not statedResults postedRegistry dataFinland
1 trial · 1 completed · 1 with posted results
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
NCT0570100713 Feb 2023 to 10 Apr 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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?
Other
Patients diagnosed with metastatic castration sensitive prostate cancer (mCSPC)
Other
Patients diagnosed with metastatic castration resistant prostate cancer (mCRPC)
Outcomes the sponsor listed as primary.
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).
Number of Participants Undergone Palliative Radiology
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 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).
Number of Participants With Symptomatic Skeletal-Related Event (SSRE)
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
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).
Number of Participants With Osteoporosis
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 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).
Number of Participants Who Were on Bone Medication
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 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).
Number of Participants Who Were on Opioids
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 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).
Number of Participants Classified Per Charlson Comorbidity Index (CCI) Scores
Time frame · Up to 5 years before the index date (index date included); retrospective available data evaluated in this study for approximately 14 months
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).
Number of Participants Classified Per Gleason Score
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 approx.14 months
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).
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: T
Time frame · Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
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.
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: N
Time frame · Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
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.
Number of Participants Based on Tumor Node Metastasis (TNM) Classification: M
Time frame · Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
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.
Number of Participants Based on Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame · Closest record during 3 months before or after the index date; retrospective available data evaluated in this study for approximately 14 months
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).
Number of Participants According to Treatment Per Treatment Line for mPC: mCSPC Participants
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 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).
Number of Participants According to Treatment Per Treatment Line for mPC: mCRPC Participants
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 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).
Overall Survival (OS)
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
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).
Time to Next Treatment (TTNT)
Time frame · 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
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.
Time to Disease Progression
Time frame · 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
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).
Number of Participants Per Factors Associated With Disease Progression to Castration Resistant
Time frame · 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
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).
Annual Incidence of mPC, mCSPC and mCRPC
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
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.
Number of Events Per Participant Year for Outpatient Clinic Contacts, Hospitalization Contacts
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
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).
Number of Days Per Participant Year for Hospital Inpatient Days
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
Number of days per participant year for hospital inpatient days were reported in this outcome measure.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Kilogram per meter square) | Spread |
|---|---|---|
| Participants Diagnosed With mCSPC | 27.9 | 12.4 |
| Participants Diagnosed With mCRPC | 27.1 | 4.7 |
| Group | Value (Nanogram per milliliter) | Spread |
|---|---|---|
| Participants Diagnosed With mCSPC | 199.7 | 704.7 |
| Participants Diagnosed With mCRPC | 92 | 396.4 |
| Group | Value (Units per liter) | Spread |
|---|---|---|
| Participants Diagnosed With mCSPC | 214.1 | 402.3 |
| Participants Diagnosed With mCRPC | 144 | 221.8 |
| Group | Value (Years) | Spread |
|---|---|---|
| Participants Diagnosed With mCSPC | 1.8 | 1.8 |
| Participants Diagnosed With mCRPC | 1.9 | 1.6 |
| Group | Value (Participants) |
|---|---|
| Participants Diagnosed With mCSPC | 444 |
| Participants Diagnosed With mCRPC | 240 |
| Group | Value (Participants) |
|---|---|
| Participants Diagnosed With mCSPC | 668 |
| Participants Diagnosed With mCRPC | 536 |
| Group | Value (Participants) |
|---|---|
| Participants Diagnosed With mCSPC | 270 |
| Group | Value (Participants) |
|---|---|
| Participants Diagnosed With mCSPC | 10 |
| Participants Diagnosed With mCRPC | 9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Participants Diagnosed With mCSPCEligible participants with mCSPC and whose data were evaluated retrospectively. | 343 / 795 | 0 / 0 | 0 / 0 |
| Participants Diagnosed With mCRPCEligible participants with mCRPC and whose data were evaluated retrospectively. | 218 / 558 | 0 / 0 | 0 / 0 |
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