Castrate Resistant Prostate Cancer Enhertu Therapy

Description

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

Conditions

Prostate Cancer Metastatic, Prostate Cancer, CRPC

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Study Overview

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Study Details

Study overview

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fam-Trastuzumab Deruxtecan-Nxki (T-DXd) As a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma

Castrate Resistant Prostate Cancer Enhertu Therapy

Condition
Prostate Cancer Metastatic
Intervention / Treatment

-

Contacts and Locations

Washington DC

Washington DC VAMC, Washington DC, District of Columbia, United States, 20422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically confirmed adenocarcinoma of the prostate
  • * Diagnosis of mCRPC
  • * Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen
  • * Ongoing ADT to maintain serum testosterone levels below 50 ng/dL
  • * Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry
  • * Life expectancy 6 months
  • * ECOG 0 or 1
  • * LVEF at least 50%
  • * Adequate Blood Clotting function
  • * Adequate Organ and Bone Marrow function
  • * Adequate Renal function
  • * Adequate Hepatic function
  • * History of interstitial lung disease or pneumonitis requiring steroids
  • * Significant coronary vascular disease
  • * Previous exposure to HER2 targeted therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington D.C. Veterans Affairs Medical Center,

Maneesh Jain, MD, STUDY_CHAIR, Washington DC VA Medical Center

Eric Knoche, MD, PRINCIPAL_INVESTIGATOR, VA St. Louis Healthcare System

Linda Verkruyse, MD, PRINCIPAL_INVESTIGATOR, VA Kansas City

Rhonda Bitting, MD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center

Julie Graff, MD, PRINCIPAL_INVESTIGATOR, Portland VA Medical Center

Bruce Montgomery, MD, PRINCIPAL_INVESTIGATOR, VA Puget Sound HCS

David Kosoff, MD, PRINCIPAL_INVESTIGATOR, Wisconsin VA Medical Center

Fayez Estephan, MD, PRINCIPAL_INVESTIGATOR, George Washington University Cancer Center

Study Record Dates

2028-10