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Which prostate cancer drug is kinder to your brain? new study aims to find out

NCT ID NCT04335682

Knowledge-focused Sponsor: Alliance Foundation Trials, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how two prostate cancer drugs, darolutamide and enzalutamide, affect thinking and memory in men with advanced prostate cancer. About 111 men took one of the two drugs and completed computer-based cognitive tests over time. The goal was to see if one drug causes fewer mental side effects than the other.

What this could mean

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

Active substance
darolutamide and enzalutamide
What this could lead to
If successful, this study could help doctors choose which drug is less likely to cause thinking or memory problems in men with prostate cancer.
What could go wrong
This is a small, early-phase study (111 participants) that only measures cognitive changes, not overall survival or cancer control. Results may not apply to all patients.

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

111 people

The number who actually took part.

Started

Aug 2021

Finished

May 2026

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.

Key inclusion criteria include: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non- metastatic CRPC (M0CRPC) * For mCRPC: metastatic disease documented by standard or novel imaging techniques * OR for M0CPRC: no evidence of metastatic disease on standard imaging. * OR mHSPC * Surgically or medically castrated, with testosterone levels of \<50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Able to complete cognitive testing and patient reported outcome surveys in English. * Ability to swallow study medications whole. * Able to provide informed consent.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

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

Castrate resistant prostate cancer Hormone-sensitive prostate cancer Metastatic prostate cancer Non-metastatic prostate cancer Prostate cancer Prostate cancer metastatic

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • University of California - San Francisco at Mount Zion

    San Francisco, California, 94115, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

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