Prostate Cancer
Conditions
Interventions
Intervention Group:Enzalutamide
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0–1; 3. Diagnosed with non-metastatic hormone-sensitive prostate cancer (nmHSPC) by ECT/MRI or other imaging modalities; 4. History of radical prostatectomy (RP); 5. For patients 6–8 weeks post-RP: PSA levels of 0.1–0.2 ng/mL who are unwilling or ineligible for radiotherapy; or PSA levels 20 ng/mL, meeting at least one criterion) and unwilling or ineligible for radiotherapy; 6. Fully informed about the study and voluntarily signed a written informed consent form; 7. Expected survival of more than 12 months.
Exclusion criteria
Exclusion criteria: 1. Patients will be excluded from enrollment if they meet any of the following criteria: Presence of other malignancies; 2. History of surgical castration; 3. Prior hormonal therapy within 9 months before randomization; 4. Evidence of lymph node involvement or distant metastasis; 5. Contraindications to endocrine therapy; 6. Inability to tolerate oral medications; 7. Any other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undetectable PSA Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate specific antigen progression free survival;Biochemical recurrence free survival;Patient-reported outcome;Metastasis free survival; | — |
Countries
China
Contacts
Public ContactJie Li
Lishui Central Hospital
Outcome results
None listed