NCT07299292 Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
| NCT ID | NCT07299292 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | SMED Clinical Research |
| Condition | Prostate Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Frequently Asked Questions
Who can join the NCT07299292 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07299292 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07299292 currently recruiting?
Yes, NCT07299292 is actively recruiting participants. Visit ClinicalTrials.gov or contact SMED Clinical Research to inquire about joining.
Where is the NCT07299292 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Hermosillo, Spain, Santa Cruz de la Sierra, Spain.
Who is sponsoring the NCT07299292 clinical trial?
NCT07299292 is sponsored by SMED Clinical Research. The trial plans to enroll 60 participants.
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