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

NCT07299292 | Recruiting Phase 2

• 1 other identifier: TN-2025-0003
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

prostate cancer; castration; abiraterone; hormonal intensification

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response per PCWG3

  3 months

Study Arms (1)

single-cohort

EXPERIMENTAL

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

Drug: Abiraterone 250 mg with food + prednisone

Interventions

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

single-cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SMED Clinical Research: lead

Study Sites (3)

Hospital Carlos A Durand

Buenos Aires, 5044, Argentina

RECRUITING

Hospital San José

Hermosillo, Spain

NOT YET RECRUITING

Instituto Oriente Boliviano

Santa Cruz de la Sierra, 10260, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

abiraterone; Food; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Initial Intervention (Day 0-40): * Day 0: Testosterone and PSA measurement. * Abiraterone acetate 250 mg PO with lunch. * Prednisone 5-10 mg/day (either 5 mg/day or 5 mg every 12 h, at investigator's discretion). * No ADT until completion of Day 30 evaluation. * After Day 30: * If the patient achieves castration (primary endpoint met) or not, continue standard indicated treatment (add ADT from Day 31, continue AAP as planned, ± docetaxel/AAP).

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

AR (1); ES (2)