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Could a daily pill replace hormone shots for prostate cancer?

NCT ID NCT07299292

Disease control Sponsor: SMED Clinical Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether taking abiraterone 250 mg with food and prednisone can lower testosterone to castration levels in prostate cancer patients, without using standard hormone-blocking injections or surgery. The study enrolls 60 men with prostate cancer who need hormone therapy. If it works, it could offer a more convenient, all-oral treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abiraterone 250 mg with food plus prednisone
What this could lead to
If successful, this could offer a simpler, pill-only option to lower testosterone in prostate cancer patients, avoiding the need for injections or surgery.
What could go wrong
This is a small, early-phase trial with only 60 participants. It may not work as well as standard treatments, and abiraterone can cause side effects like high blood pressure or liver issues.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

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

Male participants only

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: * 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.

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Conditions

The condition(s) this trial relates to.

disease prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer (diagnosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Carlos A Durand

    RECRUITING

    Buenos Aires, 5044, Argentina

  • Hospital San José

    NOT_YET_RECRUITING

    Hermosillo, Spain

  • Instituto Oriente Boliviano

    RECRUITING

    Santa Cruz de la Sierra, 10260, Spain

    Contact Email: •••••@•••••

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