Actively Recruiting
Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
Led by SMED Clinical Research · Updated on 2025-12-23
60
Participants Needed
3
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed prostate adenocarcinoma
- Treated at Hospital Durand (Argentina) or Instituto Oncol�f3gico del Oriente Boliviano (Bolivia)
- Indicated for hormonal intensification (high/very high risk candidates for radiotherapy, or metastatic hormone-sensitive prostate cancer candidates for doublet or triplet therapy)
- No prior androgen deprivation therapy (ADT)
- ECOG performance status of 0 to 2
- Adequate liver and kidney function
- Potassium level of 3.5 mmol/L or higher
- Controlled blood pressure
You will not qualify if you...
- Hypersensitivity to Abiraterone or prednisone
- Moderate to severe liver impairment
- Uncontrolled high blood pressure
- Refractory low potassium levels
- Use of medications strongly contraindicated or that affect Abiraterone levels without possibility of adjustment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Carlos A Durand
Buenos Aires, Argentina, 5044
Actively Recruiting
2
Hospital San José
Hermosillo, Spain
Not Yet Recruiting
3
Instituto Oriente Boliviano
Santa Cruz de la Sierra, Spain, 10260
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here