Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events | 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 | 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 |
| Incidence of discontinuations and dose modifications of study drug due to adverse events | 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 | Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hematology laboratory parameters: hemoglobin | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: hematocrit | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: erythrocyte count | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: leukocyte count | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: lymphocytes | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: monocytes | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: eosinophils | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: neutrophils | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: basophils | 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 | 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 | 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 | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in hematology laboratory parameters: thrombocytes | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: albumin | 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 | 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 | 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 | 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 | 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 | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: calcium | 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 | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: creatinine | 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 | 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 | 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 | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: sodium | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: potassium | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: chloride | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: bicarbonate | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in clinical chemistry laboratory parameters: testosterone | 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) | 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 | 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) | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in routine urinalysis parameters: specific gravity | 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 | 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 | 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 | 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 | 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 | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | — |
| Changes in routine urinalysis parameters: microscopic examination | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | Microscopic examination, if blood or protein urinalysis by dipstick is abnormal |
| Results of other safety laboratory tests | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | Results of other safety laboratory tests performed as deemed necessary by the investigator |
| Changes in Eastern Cooperative Oncology Group performance status and vitals | Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months | Eastern Cooperative Oncology Group performance status on a scale from 0 to 5 |
| Incidence and severity of adverse events categorized as special topics | 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 | 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. |
| Drug administration status | From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months | Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose |
Countries
India
Contacts
CONTACTBayer Clinical Trials Contact
Outcome results
None listed