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An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment

Recruitingn/aAges 18 Years - anyMaleBayer
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In plain words

What the trial is, and whether it could suit you

In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Males Age โ‰ฅ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Patients receiving โ‰ฅ6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators. * Serum testosterone level\<1.7 nmol/L. * Decision to initiate treatment with ADT + Darolutamide as per investigator's routine treatment practice. * No evidence of metastasis as assessed by computed tomography (CT)/magnetic resonance imaging (MRI) for soft tissue disease and whole-body radionuclide bone scan for bone disease. * The informed consent form must be signed by the patient or his legal guardian (as applicable). * Patients who are fertile must use an effective method of contraception during the study and must refrain from donating sperm during the study or for 3 months after the end of treatment, unless they have undergone a radical prostatectomy. Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice. * Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement. * Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor). * Previous treatment with 2nd-generation ARIs. * Previous treatment with CYP17 inhibitors. * Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC. * Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias. * Gastrointestinal diseases affecting absorption.
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What it tests

  • Darolutamide
  • ADT
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Where

1 site
Many locations
Multiple Locations, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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