RECRUITINGPhase 2INTERVENTIONAL
Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥18 years.
- diagnosed by tissue sample (biopsy-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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Abiraterone 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