Study on REGN2810 and Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer

Sponsor: Mark Stein

Sponsor score: 0

ClinicalTrials ID:NCT03951831

This clinical trial is testing a combination of treatments, including REGN2810, hormone therapy, and chemotherapy, to see if they are safe and effective for patients with newly diagnosed metastatic hormone-sensitive prostate cancer.

Patient Parameters

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Program Overview

The main goal of this study is to find out if a combination of treatments—REGN2810, hormone therapy, and chemotherapy—can safely and effectively lower prostate-specific antigen (PSA) levels in patients with newly metastatic hormone-sensitive prostate cancer. Researchers will measure the success of the treatment by checking if PSA levels become undetectable within six months of starting the combination therapy.

Description

This study aims to improve treatment for metastatic hormone-sensitive prostate cancer by using a combination of REGN2810, hormone therapy, and chemotherapy. Traditional trials for this type of cancer take a long time because they focus on overall survival rates. This study uses a different approach by looking at early signs of treatment success, like undetectable PSA levels, to speed up the process of finding effective treatments. By focusing on these early indicators, researchers hope to provide quicker insights into how well the treatment works.

Eligibility Criteria

Inclusion Criteria

Be willing and able to provide written consent to participate.
Be 18 years or older.
Have a life expectancy of more than 12 months.
Have a good performance status, meaning you can carry out daily activities with little or no assistance.
Have confirmed prostate cancer through medical tests.
Have metastatic cancer that can be measured or evaluated.
Have a testosterone level of at least 150 ng/dL.
Have not been on hormone therapy or certain cancer drugs for at least 6 months before joining the study.
Have not received chemotherapy or immunotherapy for prostate cancer.
Have not had surgery to remove both testicles.
Have not received radiation therapy within 14 days of starting the study treatment.
Have adequate organ and blood function based on specific medical tests.
Agree to undergo tumor biopsies unless medically advised otherwise.
Agree to use effective contraception during the study and for 4 months after the last dose of REGN2810.

Exclusion Criteria

Have received hormone therapy or certain cancer drugs within 6 months before joining the study.
Have received prior immunotherapy or chemotherapy for prostate cancer.
Have received radiation therapy within 2 weeks before joining the study.
Are currently taking other investigational drugs.
Have had an organ or bone marrow transplant.
Have an active autoimmune disease requiring treatment in the past 2 years.
Have a diagnosis of immunodeficiency or are taking immunosuppressive drugs.
Have another type of cancer that could interfere with the study.
Have a history of lung disease or non-infectious lung inflammation.
Have severe nerve damage.
Have an active infection requiring treatment.
Have any condition that could interfere with the study results or participation.
Have a history of psychiatric or substance abuse disorders that could affect participation.
Have HIV or untreated active Hepatitis B.
Have received a live vaccine within 30 days before starting the study.
Have a history of severe allergic reactions to docetaxel or similar drugs.

Locations

FACILITY	ZIP	CITY	STATE
Columbia University Irving Medical Center	10032	New York	New York

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