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New drug combo for tough prostate cancer shows early promise, but trial halted

NCT ID NCT05999968

Disease control Sponsor: Eli Lilly and Company 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a combination of two oral drugs, abemaciclib and darolutamide, in 10 men with metastatic castration-resistant prostate cancer that had spread despite standard hormone therapy. The main goal was to check safety and side effects. The trial was terminated early, so results are limited, but researchers were looking for signs that the combination could slow cancer growth.

What this could mean

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

Active substance
abemaciclib and darolutamide
What this could lead to
If it works, this could point toward a new combination treatment for advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This was a very early, small phase 1 trial that was terminated early, so results are limited. The combination may cause serious side effects and may not improve outcomes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Jan 2024

Finished

Jan 2026

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: * Histologically confirmed adenocarcinoma of the prostate. * Metastatic castration-resistant prostate cancer evidenced by: * Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone * At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI) * Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study. * Have adequate organ function. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: * Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide. * Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals. * Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. * Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma 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

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Infanta Cristina

    Badajoz, 06006, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 8907, Spain

  • Klinikum Rechts Der Isar Der Technischen Universität München

    Munich, Bavaria, 81675, Germany

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538, Germany

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