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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 2Ages 18 Years - anyMaleSMED Clinical Research
NCT07299292 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Abiraterone 250 mg with food + prednisone
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Where

3 sites
Hospital Carlos A Durand
Buenos Aires, Argentina
Hospital San José
Hermosillo, Spain
Instituto Oriente Boliviano
Santa Cruz de la Sierra, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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