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Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up Men only

Castration using low-dose abiraterone plus prednisone without LHRH therapy for prostate cancer needing hormonal intensification

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

Run by SMED Clinical Research · NCT07299292 · Data updated 2026-11-12

This tests whether taking abiraterone 250 mg with food plus prednisone can lower testosterone to castration levels within 30 days in men with prostate cancer who need hormonal intensification without using LHRH analogs.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment60 (estimated)
SponsorSMED Clinical Research
Academic / other
Drugs / interventionsprednisone
Locations3 sites (Buenos Aires and 2 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2026
Study endsMarch 30, 2027
Registry record updatedDecember 23, 2025
Trial IDNCT07299292 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged ≥18 with histologically confirmed prostate adenocarcinoma who are candidates for hormonal intensification (high/very-high risk for radiotherapy or mHSPC planned for abiraterone doublet/triplet), with no prior ADT, ECOG 0–2, adequate labs, and treated at a participating center are ideal candidates.

Probably not a fit

Patients with prior ADT, uncontrolled hypertension, moderate-to-severe hepatic impairment, refractory hypokalemia, known hypersensitivity to abiraterone or prednisone, or on contraindicated interacting medications are unlikely to benefit from this regimen.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, prospective, open-label, multicenter single-cohort trial giving abiraterone 250 mg with food plus daily prednisone to men eligible for hormonal intensification while withholding standard LHRH analogs for the first 30 days. Eligible patients include high/very-high risk localized cases planned for radiotherapy and metastatic hormone-sensitive patients planned for doublet or triplet therapy, all without prior ADT. The primary endpoint is the proportion achieving serum testosterone ≤50 ng/dL at Day 30 (with sensitivity analysis at ≤20 ng/dL) and time to castration; secondary endpoints include early PSA changes and safety monitoring for hypertension, hypokalemia, hepatotoxicity, fluid retention, and adrenal insufficiency. Visits include screening, Day 0 start of therapy, Day 30 endpoint evaluation, and safety follow-up to Day 60 at participating centers in Argentina, Mexico, and Bolivia.

Why it matters

Potential benefit: If successful, this approach could provide a faster, oral way to achieve castration-level testosterone without injectable LHRH therapy, potentially accelerating access to intensified treatment and reducing costs.

How similar studies have gone: Some pharmacokinetic and small clinical studies indicate that abiraterone 250 mg taken with food can achieve similar drug exposure and testosterone suppression to standard dosing, but replacing LHRH analogs with low-dose abiraterone alone has not been widely validated in large trials.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hospital Carlos A Durand
    Buenos Aires, Argentina     Recruiting
  • Instituto Oriente Boliviano
    Santa Cruz de la Sierra, Spain     Recruiting
  • Hospital San José
    Hermosillo, Spain     Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.