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A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

NCT06661122 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-19

No results posted yet for this study

Summary

This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen deprivation therapy (ADT) and docetaxel, will be collected and studied.

The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for another type of prostate cancer. To better understand the impact of this combination therapy on low-volume mHSPC and make better treatment choices, more knowledge is needed. ADT is a hormone therapy that lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Darolutamide blocks androgen signals to slow the growth of the cancer cells. Docetaxel is a type of chemotherapy used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.

The prostate gland is a male reproductive gland found below the bladder. Low-volume mHSPC is a cancer of the prostate gland that has spread beyond the gland to three or fewer bones but has not reached organs like the lungs and liver. The prostate cancer is considered hormone sensitive when it responds to an anti hormonal therapy.

In this study, only observations from routine clinical practices will be made. Participants will receive darolutamide, in combination with ADT and docetaxel as prescribed by their doctors during routine medical care. The participants will not receive any advice on treatment or any changes to healthcare as a part of the study.

The main purpose of this study is to learn more about how safe darolutamide is and how well it works in combination with ADT and docetaxel in adult Japanese men with mHSPC in routine medical care.

To do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors:

• the number of participants who achieve normal levels of prostate specific antigen (PSA).

PSA is a protein found in the blood that helps doctors monitor prostate cancer.

• the number of participants who have adverse events (AEs), serious adverse events (SAEs), and adverse events of special Interest (AESIs) that lead to discontinuation or change in the dose of darolutamide or docetaxel during the study.

AEs are medical problems that the participants had during the study that may or may not be related to the study treatment.

SAEs are AEs that lead to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby to be born with medical problems, or is medically important.

AESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc.

The data will come from the participant's medical records and will be collected between October 2024 and June 2031. Researchers will only look at the health records from adult men with mHSPC in Japan. No separate visits are required as part of the study. The participants will only visit their doctor at the study clinic as part of their routine medical care.

Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
  • Low-volume Metastasis

Interventions

DRUG

Darolutamide (BAY1841788) + docetaxel + ADT

Follow clinical practice/administration. ADT=androgen deprivation therapy.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2031-03-31
Completion
2031-08-31

Countries

  • Japan

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661122 on ClinicalTrials.gov