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Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.

NCT05276492 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-03

No results posted yet for this study

Summary

Doctors leading this study plan to collect new information about the lowest effective dose of abiraterone acetate in study participants with prostate cancer who are taking abiraterone in combination with prednisone for the first time. The duration of this study will be about 3 months (12 weeks). How long you stay on abiraterone, and at what dose after completion of the 12 weeks of study drug administration, will be up to you and your treating physician.

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Neoplasm
  • Prostate Cancer Metastatic

Interventions

DRUG

Abiraterone Oral Tablet

Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.

DRUG

Prednisone tablet

Prednisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

OTHER

Drug Dairy/Log

A drug dairy/log that will the study team will give for you to document information about the study drugs and meals you take during the study.

DRUG

Low-fat meal

A low-fat meal that will be taken with abiraterone. If you have questions about what is considered "a low-fat" meal during the study, ask the study doctor or research staff.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Russell Szmulewitz, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2024-11-16
Completion
2024-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276492 on ClinicalTrials.gov