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New drug cocktail shows promise in slowing advanced prostate cancer

NCT ID NCT01314118

Disease control Sponsor: Janssen Biotech, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a combination of abiraterone acetate and prednisone in 131 men with advanced prostate cancer that had not yet spread on scans. The goal was to see if the drugs could lower PSA levels and delay cancer progression. Participants took daily pills alongside standard hormone therapy.

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 plus prednisone
What this could lead to
If successful, this combination could help men with advanced prostate cancer keep their disease under control longer before it spreads.
What could go wrong
This is a small, early-phase study without a comparison group, so results may not be definitive. Side effects from the drugs can include liver problems, high blood pressure, and fluid retention.

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

131 people

The number who actually took part.

Started

May 2011

Finished

Dec 2024

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 to 99 years

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.

Major Inclusion Criteria: * Be a male \>= 18 years of age * Have adenocarcinoma of the prostate * Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH) monotherapy for at least 6 months before or have undergone surgical removal of the testicles * Serum testosterone of \< 50 ng/dL(\< 2.0 nM) * Have rising PSA defined as a PSA of \>= 10 ng/mL obtained at screening or PSADT of ≤ 10 months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0 ng/mL * Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Be capable of swallowing study agents whole as a tablet * Be willing/able to adhere to the prohibitions and restrictions specified in this protocol Major Exclusion Criteria: * Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria * Have received chemotherapy for treatment of castrate-resistant prostate cancer; however, if a patient received chemotherapy in an adjuvant setting, prior to having CRPC, for castrate-sensitive prostate cancer, the patient is still eligible * Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or nilutamide). * If previously treated with antiandrogen therapy, there must be documentation of at least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to screening * If previously treated with flutamide, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide discontinuation. * If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation * Have previously received agents having any CYP17 inhibitory activity for the treatment of prostate cancer, such as ketoconazole * Have previously received aminoglutethimide * Have an active infection or other medical condition that would contraindicate prednisone use * Have uncontrolled hypertension * Have active hepatitis or chronic liver disease * Have clinically significant heart disease * Have poorly controlled diabetes * Have received an investigational therapeutic within 30 days of screening * Have partners of childbearing potential and are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate. * Individuals with a history of a non-prostate malignancy are ineligible for this study with the following exceptions. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: basal cell or squamous cell carcinoma of the skin

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer Prostatic neoplasm

Contacts and locations

Locations

  • Study site

    Homewood, Alabama, United States

  • Study site

    Huntsville, Alabama, United States

  • Study site

    Tucson, Arizona, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    San Francisco, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Aventura, Florida, United States

  • Study site

    Orange City, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Evanston, Illinois, United States

  • Study site

    Galesburg, Illinois, United States

  • Study site

    Glenview, Illinois, United States

  • Study site

    Melrose Park, Illinois, United States

  • Study site

    Fort Wayne, Indiana, United States

  • Study site

    Jeffersonville, Indiana, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Rockville, Maryland, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Lansing, Michigan, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Lawrenceville, New Jersey, United States

  • Study site

    Albany, New York, United States

  • Study site

    Brooklyn, New York, United States

  • Study site

    Buffalo, New York, United States

  • Study site

    Garden City, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Poughkeepsie, New York, United States

  • Study site

    Staten Island, New York, United States

  • Study site

    Chapel Hill, North Carolina, United States

  • Study site

    Raleigh, North Carolina, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Lancaster, Pennsylvania, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Greenville, South Carolina, United States

  • Study site

    Myrtle Beach, South Carolina, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Arlington, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Milwaukee, Wisconsin, United States

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