Can a lower dose of prostate cancer drug work just as well?
NCT ID NCT05276492
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Nov 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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Other studies related to the condition(s) this trial covers.
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