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
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Patients receiving ≥6 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.
You may not be if
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.
Clareo Health | 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
