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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called abiraterone at a lower dose (250 mg, instead of the standard 1000 mg) can lower testosterone enough to treat prostate cancer without needing the usual hormone-blocking injections (LHRH analogs). **You may be eligible if...** - You are 18 or older - You have confirmed prostate cancer - You are being treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia) - Your doctor has determined you need hormonal intensification (e.g., high/very-high risk candidates for radiation, or cancer that has spread) - You have not previously received hormone deprivation therapy (ADT) - You are in good health (ECOG 0-2) with adequate organ function **You may NOT be eligible if...** - You have already received hormone therapy for prostate cancer - You have serious liver problems or low potassium levels - You have uncontrolled high blood pressure - You have had a prior heart attack or serious heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(3)

Hospital Carlos A Durand

Buenos Aires, Argentina

Hospital San José

Hermosillo, Spain

Instituto Oriente Boliviano

Santa Cruz de la Sierra, Spain

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NCT07299292


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