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

NCT ID NCT06190899

Recruiting now Disease control Sponsor: Celcuity Inc Source: ClinicalTrials.gov ↗

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.

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.

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.

GENITAL DISEASES, MALE MCRPC (METASTATIC CASTRATION-RESISTANT PROSTATE CANCER) PROSTATE CANCER PROSTATIC DISEASE PROSTATIC NEOPLASMS, CASTRATION-RESISTANT UROGENITAL DISEASES, MALE

Contacts and locations

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

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