Clinical trial · Interventional
Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
NCT07299292CI-TRIAL-00099535recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone 250 mg with food + prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-cohort
- description
- Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
- interventionNames
- Drug: Abiraterone 250 mg with food + prednisone
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 3 months
- description
- Response per PCWG3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.