Nonmetastatic Castration-Resistant Prostate Cancer(nmCRPC)
Conditions
Interventions
Observation group:None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Males Age >= 18 years. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 3.Patients receiving >=6 m ADT+Bicalutamide in nmHSPC, progressed to nmCRPC judged by investigators. 4.Serum testosterone level<1.7 nmol/L. 5.Decision to initiate treatment with ADT + Darolutamide as per investigator’s routine treatment practice. 6.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. 7.The informed consent form must be signed by the patient or his legal guardian (as applicable). 8.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
Exclusion criteria: 1.Participation in an investigational program with interventions outside of routine clinical practice. 2.Presence of distant metastases, including involvement of the Central Nervous System (CNS) and vertebral or meningeal involvement. 3.Symptomatic local or regional lesions requiring medical intervention (moderate or severe urinary tract obstruction or hydronephrosis caused by the primary tumor). 4.Previous treatment with 2nd-generation ARIs. 5.Previous treatment with CYP17 inhibitors. 6.Previous treatment with radiopharmaceuticals, immunotherapy, or other investigational treatment for nmCRPC. 7.Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias. 8.Gastrointestinal diseases affecting absorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with undetectable PSA at any time within 6 months after the start of treatment;Proportion of participants who remain in PSA progression-free status at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with a >=50% reduction in PSA from baseline at 3 months and 6 months;Proportion of participants with a >=50% decrease in PSA from baseline within 12 months;Proportion of participants with a PSA decrease of >=90% from baseline at 3 months and 6 months;Proportion of participants with undetectable PSA within 3 months;Occurrence of adverse events;Proportion of participants with a >=90% decrease in PSA from baseline within 12 months;Proportion of participants with undetectable PSA within 12 months;12-month progression-free survival; | — |
Countries
China
Contacts
Public ContactDong Qiang
West China Hospital of Sichuan University
Outcome results
None listed