Health Trials

A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India

ConditionMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorBayer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Darolutamide plus androgen deprivation therapy

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single-arm post marketing surveillance cohort1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Many locations Status unavailable Many LocationsIndiaIndia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bayer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: