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

ConditionProstate Cancer (Diagnosis)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSMED Clinical Research

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Abiraterone 250 mg with food + prednisone

    Drug

    Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: single-cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate

Response per PCWG3

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SMED Clinical Research

Lead sponsor

Source ClinicalTrials.gov
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