RECRUITING

Castrate Resistant Prostate Cancer Enhertu Therapy

Conditions

Prostate Cancer Metastatic Prostate Cancer CRPC metastatic prostate cancer Enhertu HER2 positive Trastuzumab deruxtecan phase 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-05

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06610825

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Asha Escobar

CONTACT

2027431090

asha.escobar@va.gov

Principal Investigator

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 Locations (Sites)

Washington DC VAMC

Washington DC, District of Columbia, 20422

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05

Study Completion Date2028-10

Study Record Updates

Study Start Date2025-03-05

Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

prostate cancer
metastatic prostate cancer
Enhertu
HER2 positive
Trastuzumab deruxtecan
crpc
phase 2

Additional Relevant MeSH Terms

Prostate Cancer Metastatic
Prostate Cancer
CRPC