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NCT03951831 · ClinicalTrials.gov registry record · Phase 2

REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer

A Phase 2 study of Prostate Cancer Metastatic, sponsored by Mark Stein.

Active
Registry status
Phase 2
Development phase
26
Enrollment target
1
Study location

NCT03951831 is a Phase 2 study of Prostate Cancer Metastatic that is active but no longer recruiting, run by Mark Stein. The registered enrollment target is 26 participants, below the 226-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03951831, a Phase 2 study of Prostate Cancer Metastatic, is active but no longer recruiting, sponsored by Mark Stein.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37).

Conditions Studied

Prostate Cancer Metastatic

Interventions

  • DRUG Docetaxel
  • DRUG Degarelix
  • DRUG Leuprolide Acetate
  • DRUG REGN2810

Study Locations (1)

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2019-05-16
Est. Completion 2028-04
Phase Phase 2

Sponsor

Mark Stein

4 total trials

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What the Registry Record Tells You About NCT03951831

The ClinicalTrials.gov registry entry for NCT03951831 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 226-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (88% lower). The listed sponsor is Mark Stein, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT03951831 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03951831 about?

NCT03951831 is a clinical study titled "REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer". The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint o...

What is the current status of trial NCT03951831?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-05-16. Estimated completion is 2028-04.

What conditions does trial NCT03951831 study?

This clinical trial studies the following conditions: Prostate Cancer Metastatic.

What interventions are being tested in trial NCT03951831?

The interventions under investigation include: Docetaxel (DRUG), Degarelix (DRUG), Leuprolide Acetate (DRUG), REGN2810 (DRUG).

Who is sponsoring clinical trial NCT03951831?

This trial is sponsored by Mark Stein, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03951831 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.