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Clinical trialNCT05617885TerminatedPhase 1Interventional

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

SponsorPraful Ravi, MB BCHir, MRCPEnrollment9Metastatic Prostate CancerNon-metastatic Prostate CancerProstate Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AbemaciclibDarolutamideDegarelixGNRH-A GoserelinGNRH-A Leuprolide Acetate
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Aug 2023
Primary completion
15 Jul 2025
Completion
1 Jun 2026
Last update posted
15 Oct 2026
Registered enrollment
9
Registry id
NCT05617885
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.