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

RECRUITINGPhase 2Sponsored by SMED Clinical Research
Actively Recruiting
PhasePhase 2
SponsorSMED Clinical Research
Started2025-12-01
Est. completion2026-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07299292

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions2

CancerProstate Cancer (Diagnosis)

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