Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Completed · Phase 1

Conditions studied: Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer

In brief

This research study is trying to determine the safety and efficacy of the combination of two oral drugs, abemaciclib and darolutamide, with androgen deprivation therapy (ADT) in the treatment of metastatic, non-metastatic, and advanced prostate cancers. The first phase of the study is to establish a recommended dose for the second phase. The names of the study drugs and interventions involved in this study are: * Darolutamide * Abemaciclib * Androgen deprivation therapy (ADT) - this includes several different treatments, including Gonadotropin-Releasing Hormone (GnRH) antagonists and agonists It is expected that about 93 people will take part in the research study. Treatment is expected to last 6 months with a follow up period of up to 4.5 years.

Key facts

Study ID
NCT05617885
Run by
Praful Ravi, MB BCHir, MRCP
People needed
9
Starts
2023-08-09
Expected to finish
2026-06-01
Last updated by the study team
2026-06-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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