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How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany

Recruitingn/aAges 18 Years - anyMaleBayer
NCT07395804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws). Exclusion Criteria: * 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
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What it tests

  • darolutamide plus ADT treatment
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Where

1 site
Many
Locations, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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