RecruitingPhase 2NCT07299292

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

Sponsor

SMED Clinical Research

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Diagnosis)

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria2

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.

Interventions

DRUGAbiraterone 250 mg with food + prednisone

Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases