New drug duo takes on Hard-to-Treat prostate cancer

NCT ID NCT06190899

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two drugs—gedatolisib and darolutamide—together in men with metastatic castration-resistant prostate cancer (mCRPC), a type that has spread and no longer responds to standard hormone therapy. The first part finds the safest dose, and the second checks if the combo slows cancer growth. About 54 men will take part.

What this could mean

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

Active substance

gedatolisib and darolutamide

What this could lead to

If this works, it could offer a new combination treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.

What could go wrong

This is an early-phase trial with only 54 participants, so results may not apply broadly. The combination may cause side effects or fail to improve outcomes.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma male reproductive system disorder Male Urogenital Diseases prostate cancer prostate disorder Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita

    NOT_YET_RECRUITING

    Cambridge, CB20QQ, United Kingdom

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, 06100, France

  • Centre Jean Perrin

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63011, France

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, 28045, Spain

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon

    NOT_YET_RECRUITING

    Madrid, 28007, Spain

  • Institut Catala d'Oncologia

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Institut Paoli-Calmettes

    NOT_YET_RECRUITING

    Marseille, 13009, France

  • Instituto Valenciano de Oncología

    NOT_YET_RECRUITING

    Valencia, 46009, Spain

  • Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, SM25PT, United Kingdom

  • University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

    NOT_YET_RECRUITING

    Southampton, SO16 6YD, United Kingdom