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Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

NCT05617885 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-02-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Darolutamide

Tablet administered orally, per protocol, 2 x daily. Darolutamide is an orally administered molecular drug therapy that blocks the action of testosterone, the male sex hormone which can stimulate growth of prostate cancer.

DRUG

Abemaciclib

Tablet administered orally, per protocol, 2 x daily. Abemaciclib is an orally administered molecular drug therapy that is called a "CDK4/6 inhibitor". CDK4 and CDK6 are enzymes that are involved in helping healthy and cancerous cells divide and blocking these enzymes can stop cancerous cells from growing.

DRUG

GNRH-A Leuprolide Acetate

Administered via intramuscular injection, per standard of care. GnRH agonist is a hormonal therapy drug.

DRUG

GNRH-A Goserelin

Administered via subcutaneous injection, per standard of care. GnRH agonist is a hormonal therapy drug.

DRUG

Degarelix

Administered via subcutaneous injection, per standard of care. GnRH antagonist is a hormonal therapy drug.

Sponsors & Collaborators

Principal Investigators

  • Praful Ravi, MB BChir, MRCP · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2025-07-15
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617885 on ClinicalTrials.gov