Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo aims to stop prostate cancer relapse after surgery

NCT ID NCT04523207

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding apalutamide to standard hormone therapy after prostate removal surgery can keep prostate cancer from coming back in high-risk patients. 108 men who had surgery for non-spread prostate cancer took the drug combo for up to 2 years. Researchers checked if their PSA levels stayed low, which would suggest the cancer hadn't returned.

What this could mean

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

Active substance
apalutamide and androgen deprivation therapy (ADT)
What this could lead to
If successful, this combination could help prevent prostate cancer from coming back after surgery in high-risk patients.
What could go wrong
This is a small, early-phase study without a comparison group, so results may not apply broadly. Hormone therapy can cause side effects like hot flashes and fatigue.

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

108 people

The number who actually took part.

Started

Aug 2020

Finished

Oct 2023

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: * A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of \<= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer * Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator * Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician * Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1 * Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (\>=) 20 ng/ml or; Gleason Score \>= 9 in any core on biopsy or; Gleason Score \>= 8 (4+4 or 5+3) in greater than (\>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy Exclusion Criteria: * History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (\<) 2 centimeter (cm) in diameter \[short axis\] either radiographically or pathologically are allowed.) * History of bilateral orchiectomy * Received an investigational intervention \<= 4 weeks before the planned first dose of study intervention * History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide * Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostatic neoplasms are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostatic neoplasms

Contacts and locations

Locations

  • Adult Pediatric Urology & Urogynecology, P.C

    Omaha, Nebraska, 68114, United States

  • Arizona Urology Specialists

    Tucson, Arizona, 85741, United States

  • Arizona Urology Specialists 1

    Tucson, Arizona, 85704, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

  • Foothills Urology - Golden Off

    Lakewood, Colorado, 80228, United States

  • Genesis Research

    Torrance, California, 90505, United States

  • Great Lakes Physician PC d/b/a Western New York Urology Associates

    Cheektowaga, New York, 14225, United States

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • Idaho Urologic Institute

    Meridian, Idaho, 83642, United States

  • Lancaster Urology

    Lancaster, Pennsylvania, 17604, United States

  • Lexington Urology

    West Columbia, South Carolina, 20169, United States

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • New Jersey Urology LLC

    Voorhees Township, New Jersey, 08043, United States

  • Ochsner LSU Health Shreveport - Regional Urology

    Shreveport, Louisiana, 71106, United States

  • Oregon Urology Institute

    Springfield, Oregon, 97477, United States

  • Skyline Urology

    Sherman Oaks, California, 91411, United States

  • Spokane Urology

    Spokane, Washington, 99202, United States

  • The Iowa Clinic

    West Des Moines, Iowa, 50266, United States

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Urological Research Network

    Hialeah, Florida, 33016, United States

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    Austin, Texas, 78745, United States

  • Urology Of Virginia, Pllc

    Virginia Beach, Virginia, 23462, United States

  • Urology San Antonio Research

    San Antonio, Texas, 78229, United States

  • Virginia Urology

    Richmond, Virginia, 23235, United States

  • Wichita Urology Group

    Wichita, Kansas, 67226, United States

More trials for these conditions

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