Non-metastatic Castration-resistant Prostate CancerNCT06334120
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
An observational study of Non-metastatic Castration-resistant Prostate Cancer and Metastatic Hormone-sensitive Prostate Cancer, run by Bayer at 1 site in South Korea.
Trial summary
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
- What is being tested?
- Darolutamide (Nubeqa, BAY1841788)
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2024to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been prescribed Darolutamide for a medically appropriate use will be eligible to be enrolled.
Who may be able to join
- Male aged ≥19 years
- Patients with high risk nmCPRC
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])
- PSA doubling time < 10 months
- Patients with mHSPC
- histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI).
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- be candidates for androgen-deprivation therapy with/without docetaxel.
- Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice
- Written informed consent from subject or legal representative; assent from subject when appropriate
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Participants with contraindication according to the locally approved prescribing information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Many locations
Multiple Locations
About this study
Official title: Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.
This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.
Read more
To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.
Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.
- Conditions
- Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
- Being tested
- Darolutamide (Nubeqa, BAY1841788)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide (Nubeqa, BAY1841788)Drug
The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
| Study group | Role | What they receive |
|---|---|---|
| Male patients with nmCRPC or mHSPC | Male patients with a diagnosis of non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with Darolutamide has been made by the investigator. Receives: Drug: Darolutamide (Nubeqa, BAY1841788) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, severity of adverse events (including SAEs)
SAE stands for serious adverse event. An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
Number, severity of adverse drug reactions (including SADRs)
SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
Measured: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
The outcome of (serious) adverse events
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
The outcome of (serious) adverse drug reactions
An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
Measured: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
Secondary outcomes (14)
Metastasis-free survival (MFS) by nmCRPC indication
MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.
Measured: Up to 52 weeks
Time to first symptomatic skeletal event (SSE) by nmCRPC indication
Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.
Measured: Up to 52 weeks
Time to prostate-specific antigen (PSA) progression by nmCRPC indication
Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir.
Measured: Up to 52 weeks
Overall survival by nmCRPC indication
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
Measured: Up to 52 weeks
Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication
Time to mCRPC, defined as the time to PSA progression with serum testosterone being at castrate level <0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions, whatever comes first.
Measured: Up to 52 weeks
Time to first symptomatic skeletal event (SSE) by mHSPC indication
Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.
Measured: Up to 52 weeks
Time to prostate-specific antigen (PSA) progression by mHSPC indication
Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir.
Measured: Up to 52 weeks
Overall survival by mHSPC indication
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
Measured: Up to 52 weeks
Time to initiation of subsequent anti-cancer therapy by mHSPC indication
Time to initiation of subsequent anti-cancer therapy is defined as the time (months) from the initiation of Darolutamide treatment to the date of first administration of any subsequent anti-cancer therapy after discontinuation of Darolutamide.
Measured: Up to 52 weeks
Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication
Radiological progression is defined as the time (months) from the start of Darolutamide treatment to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.
Measured: Up to 52 weeks
Radiological Progression-Free Survival (rPFS) by mHSPC indication
Radiographic Progression-Free Survival (rPFS) is defined as the time (months) from the initiation of Darolutamide treatment to the date of the first radiologically confirmed disease progression or death from any cause, whichever occurs first.
Measured: Up to 52 weeks
Duration of Darolutamide treatment
Duration of Darolutamide treatment is defined as the time (months) from the start of Darolutamide treatment to the day of permanent discontinuation of Darolutamide (including death).
Measured: Up to 52 weeks
Reasons for ending Darolutamide
Measured: Up to 52 weeks
Dosage and dose modification of Darolutamide
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start25 Sep 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334120
- Sponsor's protocol ID
- 20654
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.