Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)

Recruiting now · Phase 2

Conditions studied: Prostate Cancer (Diagnosis)

In brief

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.

Key facts

Study ID

NCT07299292

Run by

SMED Clinical Research

People needed

60

Starts

2025-12-01

Expected to finish

2027-03-30

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Hospital Carlos A Durand — Buenos Aires, Argentina (enrolling)
• Instituto Oriente Boliviano — Santa Cruz de la Sierra, Spain (enrolling)
• Hospital San José — Hermosillo, Spain

Full record on ClinicalTrials.gov

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