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Taking people in ArgentinaPhase 2

Abiraterone 250 mg with prednisone for lowering testosterone in prostate cancer

Tests abiraterone 250 mg with food and prednisone in adults with prostate cancer.

Plain-language title generated from the registry record
Registry title: Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)

Key facts

Where
Buenos Aires, ArgentinaSee the site
Phase
Phase 2

Where in Argentina

  • Hospital Carlos A DurandBuenos Aires, ArgentinaTaking people

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Trial details

Who runs it
SMED Clinical Research
Trial code
NCT07299292
Record updated
23 December 2025
Original description
HypothesisRead full original descriptionShow less

Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)

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.

Inclusion: 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: Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment; Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.

ClinicalTrials.gov NCT07299292