pause_circle_filledNot Yet Recruiting

metastatic hormone-sensitive prostate cancer (mHSPC)

Bayer Identifier:
23146
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
How Darolutamide Plus Hormone Therapy Works for Men with Advanced Prostate Cancer in Everyday Medical Practice in Germany

Trial purpose

Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).
The usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.

The main goal of this study is to find out how well a combination of two treatments—darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)—works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.
The study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient’s background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient’s medical records if available. If some information is missing, the doctor may ask the patient directly.

Other information will be collected as the study goes on. This includes details about the patient’s treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient’s usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.

Key Participants Requirements

Sex

Male

Age

18 - N/A (No Limit)
    • Male patients aged ≥ 18 years
    • Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
    • Metastatic disease by conventional or new generation imaging
    • Darolutamide treatment started more than 30 days prior to study enrollment
    • ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
    • Hypersensitivity to darolutamide or any other excipient
    • Other prior systemic hormonal or anti-cancer treatment for mHSPC
    • Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
500
Trial Dates
February 2026 - February 2031
Phase
N/A
Could I Receive a placebo
No
Products
N/A
Accepts Healthy Volunteer
false

Primary Outcome

  • Number of participants with PSA < 0.2 ng/mL
    date_rangeTime Frame:
    12 months

Secondary Outcome

  • Number of deaths or participants with end of observation
    date_rangeTime Frame:
    up to 60 months
  • Number of participants with PSA < 0.2 ng/mL
    date_rangeTime Frame:
    3, 6, and 9 months
  • Number of participants with certain demographic characteristics
    - age - race
    date_rangeTime Frame:
    at study start
  • Number of participants with certain clinical characteristics
    - comorbities - Gleason score/ISUP - PSA prior therapy - prostate cancer volume and risk - type of metastatic disease - ECOG performance
    date_rangeTime Frame:
    at study start
  • Number of participants with certain testosterone value
    date_rangeTime Frame:
    at study start
  • Duration of ADT treatment
    date_rangeTime Frame:
    up to 60 months
  • Timing of ADT treatment start
    date_rangeTime Frame:
    up to 60 months
  • Dosage of ADT treatment
    date_rangeTime Frame:
    up to 60 months
  • Number of participants who change dosage of ADT treatment
    date_rangeTime Frame:
    up to 60 months
  • Number of participants with poor ADT treatment adherence
    date_rangeTime Frame:
    up to 60 months
  • Number of participants with certain reasons for darolutamide plus ADT treatment discontinuation
    date_rangeTime Frame:
    up to 60 months
  • Number of participants with certain subsequent anti-cancer therapies
    e.g. switch to triplet therapy with addition of docetaxel and restart of darolutamide plus ADT after discontinuation
    date_rangeTime Frame:
    up to 60 months
  • Number of participants with treatment-emergent adverse events
    date_rangeTime Frame:
    from start of treatment up to 60 months
  • Number of participants with certain concomitant medication - at study start - during treatment with darolutamide plus ADT
    date_rangeTime Frame:
    up to 60 months

Trial design

DAROlutamide DoUBlet therapy in daily practice (DARO-DUB) – Real-world evaluation of patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with darolutamide plus ADT in Germany
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
Open Label
Assignment
N/A
Trial Arms
N/A