Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)PACE mHSPCNCT07806591
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
An observational study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Bayer at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Darolutamide plus androgen deprivation therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 30 Nov 2026to 15 Nov 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Darolutamide plus androgen deprivation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide plus androgen deprivation therapyDrug
Also called NUBEQA, BAY 1841788
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Darolutamide plus androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 (44)
Changes in hematology laboratory parameters: hemoglobin
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: hematocrit
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: erythrocyte count
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: leukocyte count
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: lymphocytes
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: monocytes
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: eosinophils
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: neutrophils
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: basophils
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: thrombocytes
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: albumin
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: calcium
Measured: 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
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: creatinine
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: sodium
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: potassium
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: chloride
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bicarbonate
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: testosterone
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: specific gravity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Nov 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806591
- Sponsor's protocol ID
- 23276
- Acronym
- PACE mHSPC
- Status last verified
- 12 Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No