Clinical trial NCT06661122: 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
Official title: An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Low-volume Metastasis
Keywords: mHSPC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients over the age of 18 years with a diagnosis of low-volume metastasis HSPC whom the decision for treatment with darolutamide in combination with docetaxel and ADT has been made by the physician or a delegate.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of prostate.
* Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as "not" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.
* Documented diagnosis of mHSPC.
* Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.
* Start ADT within 6 months before or at the index date.
* Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.

Exclusion Criteria:

* Patients treated with docetaxel before darolutamide start.
* Participation in an investigational program with interventions outside of routine clinical practice.
* Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.
* Participation in the PASS of darolutamide in patients with mHSPC (DADOX \[NCT06010914\]).

Primary outcomes:
measure: Proportion of patients with absolute prostate-specific antigen (PSA) response at 12 months
timeFrame: after 12 months
measure: Number of patients with adverse event of special interests (AESIs), serious adverse events (SAEs) and adverse events (AEs) leading to dose modification or discontinuation of darolutamide or docetaxel at 12 months
timeFrame: after 12 months
Secondary outcomes:
measure: Real-world time to PSA progression in patients who have a documentation of PSA
timeFrame: up to 12 months
measure: Real-world time to castration-resistant prostate cancer (CRPC)
timeFrame: up to 12 months
measure: Time to initiation of subsequent systemic antineoplastic therapy
timeFrame: up to 12 months
measure: Time to first symptomatic skeletal event (SSE)
timeFrame: up to 12 months
measure: Time to initiation of opioid use for ≥7 consecutive days in patients who are opioid-free at baseline
timeFrame: up to 12 months
measure: Dosing patterns of darolutamide and docetaxel up to 12 months
timeFrame: after 12 months
measure: Summary description of patient demographics / characteristics
timeFrame: after 12 months
measure: Summary description of laboratory values
timeFrame: after 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many locations
Study officials:
References: