Study Completed

Non-metastatic castration-resistant prostate cancer

Bayer Identifier:

22744

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

An observational study, called ARASHI, to understand real-world treatment patterns and outcomes with darolutamide, enzalutamide, and apalutamide in men with non-metastatic prostate cancer in Japan

Trial purpose

This is an observational study to learn more about how three medicines—darolutamide, enzalutamide, and apalutamide—are used to treat men with non-metastatic prostate cancer (nmPC) in real-world settings in Japan. In observational studies, only observations are made without specified advice or interventions.

Non-metastatic prostate cancer (nmPC) is a type of cancer that starts in the prostate gland and has not spread to other parts of the body. Androgens are male sex hormones such as testosterone. As they stimulate the growth of prostate cancer cells, low androgen levels are needed to reduce or slow the growth of these tumors. To reduce androgen levels in prostate cancer patients, the testes are removed through surgery or radiotherapy and subsequently androgen deprivation therapy (ADT) is started.

The medicines studied in this research—darolutamide, enzalutamide, and apalutamide—are known as androgen receptor inhibitors (ARIs). These medicines work by blocking androgens from attaching to prostate cancer cells, which can help slow down or stop the growth of the cancer. These ARIs are used in addition to other hormone treatments to help control the disease.

The main goal of this study is to learn how these three ARI medicines are used in real-life medical practice in Japan, and to understand how long patients continue their treatment before stopping, switching to another medicine, or passing away. The study also aims to describe the characteristics of the patients, how well they stick to their treatment, and what happens to their health over time.

This is a retrospective, observational cohort study. This means that researchers will look back at existing medical records from a large database called Medical Data Vision (MDV), which collects information from 480 hospitals in Japan. The database includes details about treatments, diagnoses, and costs for over 45 million patients. The study will include men who started treatment with one of the three ARI medicines for the first time between 01 August 2019 and 31 October 2023.

Researchers will collect information about:
- How long patients continue their ARI treatment before stopping, switching to another ARI, or dying
- Patient characteristics, such as age, medical history, and other treatments received
- How well patients stick to their treatment (adherence), measured by the proportion of days covered by their prescriptions
- If and when the cancer progresses to metastatic prostate cancer (mPC)
- Changes in the dose of ARI medicines within 90 days of starting treatment
- Use of healthcare services, such as hospital stays, emergency department visits, and outpatient visits
- Medical and pharmacy costs during the treatment period

There are not required visits in this study and treatment will not be influenced.

Key Participants Requirements

Sex

Male

Age

18 - N/A

Inclusion Criteria
- Men diagnosed with prostate cancer (≥1 record of diagnosis for prostate cancer with International Classification of Diseases, 10th Revision [ICD-10] code C61)
- Treatment with apalutamide, darolutamide, or enzalutamide initiated for the first time in the nmPC stage during the patient identification period
- Aged ≥18 years at index date
- Received >1 medical service prior to the 6-month baseline period and within 1 year prior to the index date to ensure that patients have been observed since the start of the baseline period (ie, ≥6 months of continuous activity in the MDV dataset prior to the index date)
-Received >1 medical service 6 months after the index date to ensure at least 6 months of continuous activity in the MDV dataset after the index date unless patient died within 6 months
- Identified as having CRPC before or up to 90 days after the index date
Exclusion Criteria
- Patients with multiple ARIs recorded at the index date
- Evidence of any prescription for ARI agents or abiraterone acetate prior to the index date (eg, for localized prostate cancer)
- Other cancer diagnosis (except prostate and non-melanoma skin cancer) during the 6-month baseline period
- Evidence of metastasis any time before or 30 days after the index date (because metastasis so close to the index date likely suggests that the patient was metastatic to begin with)

Trial summary

Enrollment Goal

2746

Trial Dates

April 2024 - December 2024

Phase

N/A

Could I Receive a placebo

N/A

Products

Nubeqa (Darolutamide, BAY1841788)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many locations	Many locations, Japan

Primary Outcome

Time to ARI treatment discontinuation:
Time from index date to the date when the initial ARI treatment was discontinued. A discontinuation event was defined as the earliest of any of these events: treatment stop for at least 60 days, switching to another ARI, or death. A treatment interruption of less than 60 days was not considered a discontinuation event. Patients who did not have a discontinuation event before the end of follow-up will be censored at the patient-specific follow-up end date.
Time Frame:
Retrospective analysis from 01 AUG 2019 to 31 OCT 2023

Secondary Outcome

Baseline patient characteristics
Characterization of nmCRPC patients within each cohort
Time Frame:
Retrospective analysis from 01 AUG 2019 to 31 OCT 2023
Proportion of days covered (PDC)
PDC is one of the most common measures of adherence and is calculated by dividing the total non-overlapping days of supply by the length of a fixed time interval (3, 6, or 12 months) and by the patient-specific treatment duration. PDC is considered a relatively conservative measure. Patients with a value of ≥80% were considered adherent to therapy.
Time Frame:
Retrospective analysis from 01 AUG 2019 to 31 OCT 2023

Trial design

ARASHI: Novel androgen receptor inhibitors utilization and outcomes in patients with non-metastatic prostate cancer in Japan

Trial Type

Observational

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A