Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
Recruiting · NCT07299292 · Interventional (participants receive a specific treatment) · Lead sponsor: SMED Clinical Research
View the official record on ClinicalTrials.gov →Interventions studied
Abiraterone 250 mg with food + prednisone
What this trial is about
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 can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
3 locations listed.
- Hospital Carlos A Durand - Buenos Aires, Argentina
- Hospital San José - Hermosillo, Spain
- Instituto Oriente Boliviano - Santa Cruz de la Sierra, Spain