check_circleStudy Completed
Non-Metastatic castration-resistant prostate cancer
Bayer Identifier:
22331
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study to Understand Treatment Combinations and Experiences in Spanish Men With Non-Metastatic Castration-Resistant Prostate Cancer Who Received Darolutamide in a Previous Study Called ARAMIS
Trial purpose
This is an observational study in which data already collected from Spanish men with non-metastatic castration-resistant prostate cancer (nmCRPC) who were already treated with darolutamide and followed up in previous studies (ARAMIS or ROS) are studied.
In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.
Non-metastatic castration-resistant prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder that has not yet spread to other parts of the body and does not respond to lowering testosterone (male hormone) in the body with a high risk for progressing.
Darolutamide is an approved drug for non-metastatic castration-resistant prostate cancer. Darolutamide works by blocking the androgen signals to slow the growth of the cancer cells thereby reducing the risk of death.
There are many anticancer treatments available for people with metastatic and non-metastatic prostate cancer. However, there is limited information on the treatment patterns of participants who received darolutamide for non-metastatic prostate cancer in routine medical care.
The main purpose of this study is to learn more about the treatment combinations and experiences of the Spanish men with nmCRPC who received darolutamide in previous studies.
To do this, researchers will collect information on:
- the anticancer treatments received
- when they started and stopped taking darolutamide and other anticancer treatments
- why did they stop darolutamide and other anticancer treatments
The data will come from electronic healthcare records from the Urology and Oncology Departments of 18 selected hospitals in Spain of ARAMIS study for Spanish men who were diagnosed with mCRPC between November 2023 to March 2024. They will look at the data from when they started taking darolutamide until before they joined another study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.
Non-metastatic castration-resistant prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder that has not yet spread to other parts of the body and does not respond to lowering testosterone (male hormone) in the body with a high risk for progressing.
Darolutamide is an approved drug for non-metastatic castration-resistant prostate cancer. Darolutamide works by blocking the androgen signals to slow the growth of the cancer cells thereby reducing the risk of death.
There are many anticancer treatments available for people with metastatic and non-metastatic prostate cancer. However, there is limited information on the treatment patterns of participants who received darolutamide for non-metastatic prostate cancer in routine medical care.
The main purpose of this study is to learn more about the treatment combinations and experiences of the Spanish men with nmCRPC who received darolutamide in previous studies.
To do this, researchers will collect information on:
- the anticancer treatments received
- when they started and stopped taking darolutamide and other anticancer treatments
- why did they stop darolutamide and other anticancer treatments
The data will come from electronic healthcare records from the Urology and Oncology Departments of 18 selected hospitals in Spain of ARAMIS study for Spanish men who were diagnosed with mCRPC between November 2023 to March 2024. They will look at the data from when they started taking darolutamide until before they joined another study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Key Participants Requirements
Sex
MaleAge
N/ATrial summary
Enrollment Goal
85Trial Dates
October 2023 - February 2024Phase
Phase 4Could I Receive a placebo
N/AProducts
Nubeqa (Darolutamide, BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Completed | Many Locations | Many Locations, Spain |
Primary Outcome
- Percentage of patients that received each treatment after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
Secondary Outcome
- Number of patients that received darolutamide who progressed to mCRPCdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Metastasis-free survival (MFS) is defined as the length from the index date to the date of metastasis or death, whichever occurred first. The analysis of metastasis free survival will be described using Kaplan-Meier curves and the median, 95%CI, censored and events will be presented, darolutamide start date during the ARAMIS trial will be considered the index datedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Percentage of patients who received each sequence of treatments according to standard clinical practice in Spain after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Mean of duration of treatments received in Spain after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Percentage of reasons for treatment discontinuationdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Median number of lines of treatment received by Spanish patients included in the ARAMIS study or in ROS study after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Percentage of patients who received palliative radiotherapy after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Percentage of patients who received denosumab and bisphosphonates after darolutamidedate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Patient and disease characteristics at start of treatment with darolutamide: Mean age, Percentage of patients with each ECOG PS, Percentage of patients with regional pathologic lymph nodes at ARAMIS entrydate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- At study inclusion: Mean PSA and PSA doubling time, Percentage of patients with each clinical stage, Percentage of patients with each metastatic locationdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- At prostate cancer diagnosis: Mean PSA, Percentage of patients with each Gleason score, Percentage of patients with each clinical sdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Previous therapies for prostate cancer: Mean number of previous hormonal lines, Percentage of patients who received previous radiotherapy for prostate cancer, Percentage of patients with previous surgery for prostate cancerdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
- Darolutamide treatment after end of trial end: Mean treatment duration, Percentage of patients with dose reductions, Percentage of patients with dose interruptionsdate_rangeTime Frame:Retrospective analysis from 17-Oct-2023 to 13-Mar-2024
Trial design
Trial Type
ObservationalIntervention Type
N/ATrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A