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Veterans study to reveal best prostate cancer pill

NCT ID NCT05422911

Disease control Sponsor: Sun Pharmaceutical Industries Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing three different drugs—abiraterone acetate, enzalutamide, and apalutamide—in 192 veterans with castrate-sensitive prostate cancer that has spread. The goal is to see which drug works best as a first treatment when combined with hormone therapy. Researchers will measure tumor growth rates and PSA levels to compare effectiveness.

What this could mean

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

Active substance
abiraterone acetate, enzalutamide, or apalutamide
What this could lead to
If successful, this study could help identify which of these three drugs is most effective for veterans with prostate cancer, potentially improving treatment choices and outcomes.
What could go wrong
This is a phase 2 trial with only 192 participants, so results may not apply to all patients. The study is also observational in part, so it may not prove one drug is definitively better than another.

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 192 people

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

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Veterans must meet the following to be eligible to participate: * Be willing and able to provide written informed consent for the trial. * Age ≥18 years of age on day of signing informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death). * Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis. * Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration). * Laboratory tests meet minimum safety requirements: * Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) \[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN\]. * Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl * Hematological: Platelet count ≥100,000/mm\^3; Hemoglobin \>9 g/dL; ANC \>1 X10\^9/L * Serum potassium \>3 mEq/L Exclusion Criteria: Subjects with any of the following will not be enrolled: * Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo). * Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization. * History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). * Patients who are receiving any other investigational agents concurrently. * Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease. * Child-Pugh Class B and C

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis prostate cancer prostate carcinoma prostate neoplasm

As listed by the trial registrant

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

Castrate sensitive prostate cancer Castrate-sensitive Metastatic cancer Neoplasm, prostate

How to take part

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

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Corporal Michael J. Crescenz VA Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • James A. Haley Veterans Administration Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • James J. Peters VA Medical Center

    RECRUITING

    The Bronx, New York, 10468, United States

  • Michael E. DeBakey VA Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • VA Ann Arbor Healthcare System

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • VA Greater Los Angeles Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

  • VA Hudson Valley Health Care System

    RECRUITING

    Wappingers Falls, New York, 12590, United States

  • VA New York Harbor Healthcare System

    RECRUITING

    New York, New York, 10010, United States

  • VA Portland Health Care System

    RECRUITING

    Portland, Oregon, 97239, United States

  • VA Puget Sound Health Care System

    RECRUITING

    Seattle, Washington, 98108, United States

  • VA St. Louis Health Care System

    RECRUITING

    St Louis, Missouri, 63106, United States

  • W.G. Bill Hefner Medical Center

    RECRUITING

    Salisbury, North Carolina, 28144, United States

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