Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prost
Hypothesis The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
| Condition(s) | Prostate Cancer (Diagnosis) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Hypothesis The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases. |
| Who can participate | Inclusion Criteria: * Age ≥18 years. * Histologically confirmed prostate adenocarcinoma. * Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia). * Indicated for hormonal intensification (high/very high risk candidates for RT, or mHSPC for doublet/triplet). * No prior ADT. * ECOG 0-2; adequate hepatic/renal function; K+ ≥3.5 mmol/L; controlled BP. Exclusion Criteria: * Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia. * Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment. |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | SMED Clinical Research |
| Locations | Buenos Aires, Argentina; Hermosillo, Spain; Santa Cruz de la Sierra, Spain |
| Start date | 2025-12-01 |
| NCT ID | NCT07299292 |
| Official listing | https://clinicaltrials.gov/study/NCT07299292 |