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

NCT ID NCT05999968

Terminated Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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.

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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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