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Can a lower dose of prostate cancer drug work just as well?

NCT ID NCT05276492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether men with prostate cancer could take a lower dose of the drug abiraterone (combined with prednisone) and still control their cancer. About 50 men who had never taken abiraterone before were enrolled. The goal was to find the smallest dose that still lowers hormone levels and keeps PSA in check, potentially reducing side effects. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed prostate cancer with plans to initiate abiraterone acetate * Have never received prior abiraterone or other androgen receptor modulators, including enzalutamide, apalutamide, or darolutamide. * Must have a baseline DHEA-S level of \>20 mg/dL (in order to adequately assess DHEA-S response) * A minimum washout of 28 days for any other anticancer therapy other than medical or surgical castration, prior to first dose of study drug is required. * Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug. * Denosumab or zoledronic acid are allowed. * Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix A). * Participants must have normal hepatic function as defined by clinical lab values set by the study doctor/research team. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease Prostate-Specific Antigen levels or any systemic corticosteroid (other than prednisone ≤10mg/day) within 4 weeks prior to first dose of study drug. * Inability to swallow capsules or known gastrointestinal malabsorption. * Blood pressure that is not controlled despite \> 2 oral agents (SBP \>160 and DBP \>90 documented during the screening period with no subsequent blood pressure readings \<160/100). * Serum K+ \< 3.5 mmoL/L. Patients with a K+ \< 3.5 mmoL/L are required to have a documented subsequent K+ \>3.5 prior to enrollment to be eligible. * Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled. * Active psychiatric illness/social situations that would limit compliance with protocol requirements. * Serious heart issues/congestive heart failure as assessed by New York Heart Association's definition of class II, class III, or IV congestive heart failure. * Taking other medications or drugs with strong inhibitors or inducers of CYP3A4 (See Section 8.12 below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions with abiraterone.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.