An observational study in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by Bayer. Not yet recruiting at 1 site in India. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bayer · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Darolutamide plus androgen deprivation therapy
Drug page: Darolutamide
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.
Also known as: NUBEQA, BAY 1841788
Incidence and severity of adverse events and serious adverse events
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
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
Incidence of discontinuations and dose modifications of study drug due to adverse events
Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Changes in routine urinalysis parameters: microscopic examination
Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests
Results of other safety laboratory tests performed as deemed necessary by the investigator
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in Eastern Cooperative Oncology Group performance status and vitals
Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Incidence and severity of adverse events categorized as special topics
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: * hypertension * vasodilatation and flushing * diabetes mellitus and hyperglycemia * cardiac arrhythmias * fatigue * rash * bone fracture, excluding pathological fractures * coronary artery disorders * decreased weight * mental-impairment disorder * falls, including accident * heart failure * depressed-mood disorder * seizures * gynecomastia * cerebral ischemia.
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
Drug administration status
Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
Time frame: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
Start is estimated for Nov 2026; primary completion for Nov 2028, 23 months later.
Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 23 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
Start moved twice since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, last on Oct 20, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2028 → Nov 2028, on Oct 6, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2028 → Nov 2028, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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