A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
September 9, 2026 updated by: Bayer
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bayer Clinical Trials Contact
- Phone Number: 4930300139003
- Email: clinical-trials-contact@bayer.com
Study Locations
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Many Locations, India
- Many locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male patients with a diagnosis of metastatic hormone sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with darolutamide has been made by the physician.
Description
Inclusion Criteria:
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease (metastatic hormone sensitive prostate cancer) 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 investigators
- The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice
- Written informed consent
Exclusion Criteria:
- Participation in an interventional clinical trial program with interventions outside of routine clinical practice
- Any condition that, in investigator's opinion, precludes reliable safety follow-up.
- Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
- Known hypersensitivity to the study drug or any of its ingredients
- Metastatic castration resistant prostate cancer (mCRPC) disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Single-arm post marketing surveillance cohort
Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice
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Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT).
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence and severity of adverse events and serious adverse events
Time Frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Incidence of discontinuations and dose modifications of study drug due to adverse events
Time Frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in hematology laboratory parameters: hemoglobin
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: hematocrit
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: erythrocyte count
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: leukocyte count
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: lymphocytes
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: monocytes
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: eosinophils
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: neutrophils
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: basophils
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular volume
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: thrombocytes
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: albumin
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: calcium
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: creatinine
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: serum glucose
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total protein
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: sodium
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: potassium
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: chloride
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bicarbonate
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: testosterone
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: prothrombin time
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: specific gravity
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: pH, by dipstick
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: glucose, by dipstick
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: protein, by dipstick
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: blood, by dipstick
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: ketones, by dipstick
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: microscopic examination
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests performed as deemed necessary by the investigator
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in Eastern Cooperative Oncology Group performance status and vitals
Time Frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Incidence and severity of adverse events categorized as special topics
Time Frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as:
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From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
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Drug administration status
Time Frame: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
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From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 5, 2026
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2028
Study Registration Dates
First Submitted
August 18, 2026
First Submitted That Met QC Criteria
September 1, 2026
First Posted (Actual)
September 8, 2026
Study Record Updates
Last Update Posted (Actual)
September 10, 2026
Last Update Submitted That Met QC Criteria
September 9, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23276
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.