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NCT07299292RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
9 Dec 2025
Start date
1 Dec 2025
Primary completion date
31 Dec 2026
Lead sponsor
SMED Clinical Research
NCT number
NCT07299292

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 1 Dec 2025 to the primary completion date, 31 Dec 2026
  • 3 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment.

Other illness

  • Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Carlos A Durand
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Hospital San José
Coordinator of this site? Confirm its status
HermosilloSpainNot yet recruiting
Instituto Oriente Boliviano
Coordinator of this site? Confirm its status
Santa Cruz de la SierraSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.