Trial Outcomes & Findings for Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (NCT NCT05701007)

Eligible participants aged \>=18 years who were diagnosed with metastatic prostate cancer (mPC)- metastatic castration sensitive prostate cancer (mCSPC) and/or metastatic castration resistant prostate cancer (mCRPC) between 01-Jan-2014 and 31-Dec-2022 (approximately 9 years) were identified from Pirkanmaa Hospital District (PHD) data records and their data were included in this study.

Available data from eligible participants was evaluated in approximately 14 months (study start date: 13-Feb-2023 to study completion date:10-Apr-2024) of this retrospective, observational study as per its objectives.

Participants were not exclusive in mCSPC and mCRPC cohorts.

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).

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).

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).

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).

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 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 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 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 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).

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 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 (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 (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).

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).

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).

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.

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.

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.

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 (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 (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).

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).

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 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).

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).

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 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 were reported in this outcome measure.