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NCT05617885 · ClinicalTrials.gov registry record · Phase 1

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Q: What is the current status of trial NCT05617885?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-08-09. Estimated completion is 2026-06-01.

Q: What conditions does trial NCT05617885 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer, Non-metastatic Prostate Cancer.

Q: What interventions are being tested in trial NCT05617885?

The interventions under investigation include: Darolutamide (DRUG), Abemaciclib (DRUG), Degarelix (DRUG), GNRH-A Leuprolide Acetate (DRUG), GNRH-A Goserelin (DRUG).

Q: Who is sponsoring clinical trial NCT05617885?

This trial is sponsored by Praful Ravi, MB BCHir, MRCP, which has 1 total clinical trials registered on ClinicalTrials.gov.

Q: Where is trial NCT05617885 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

A Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by Praful Ravi, MB BCHir, MRCP.

Compiled by PlainTrial · August 8, 2026

Active
Registry status: Phase 1
Development phase: 9
Enrollment target: 1
Study location

NCT05617885: Active Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by Praful Ravi, MB BCHir, MRCP.

NCT05617885 is a Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer that is active but no longer recruiting, run by Praful Ravi, MB BCHir, MRCP. The registered enrollment target is 9 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05617885, a Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Praful Ravi, MB BCHir, MRCP.

ACTIVE NOT RECRUITING
Registry status: Phase 1
Development phase: 9 participants
Enrollment target: 1
Study location

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.

Primary Outcome

The Maximum Tolerated Dose (MTD) for the study drug combination is defined as the maximum dose combination at which \<33% of patients experience a Dose limiting toxicity (DLT) during Cycle 1 (the DLT-evaluation period). If a DLT is observed in 1 of 3 patients, then 3 additional patients will be enrolled at that same dose level. Dose escalation will continue to a dose of abemaciclib 200mg bid, which is the maximal dose levels. If DLTs are seen in 0-1 of 6 patients at dose level +1 (darolutamide 6

Conditions Studied

Prostate Cancer Metastatic Prostate Cancer Non-metastatic Prostate Cancer

Interventions

DRUG Darolutamide
DRUG Abemaciclib
DRUG Degarelix
DRUG GNRH-A Leuprolide Acetate
DRUG GNRH-A Goserelin

Study Locations (1)

Massachusetts

Dana-Farber Cancer Institute - Boston

Trial Details

Field	Value
Enrollment Target	9 participants
Start Date	2023-08-09
Est. Completion	2026-06-01
Phase	Phase 1

Praful Ravi, MB BCHir, MRCP

1 total trials

What the registry record for NCT05617885 still lists

NCT05617885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (99% lower).

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Darolutamide is the first listed.

NCT05617885 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05617885 about?

NCT05617885 is a clinical study titled "Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer". 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...

What is the current status of trial NCT05617885?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-08-09. Estimated completion is 2026-06-01.

What conditions does trial NCT05617885 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer, Non-metastatic Prostate Cancer.

What interventions are being tested in trial NCT05617885?

The interventions under investigation include: Darolutamide (DRUG), Abemaciclib (DRUG), Degarelix (DRUG), GNRH-A Leuprolide Acetate (DRUG), GNRH-A Goserelin (DRUG).

Who is sponsoring clinical trial NCT05617885?

This trial is sponsored by Praful Ravi, MB BCHir, MRCP, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05617885 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05617885's enrollment target sits among peer trials

9 724th of 735 higher than 9 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05617885, the US trial registry maintained by the National Library of Medicine. NCT05617885 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.