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Castrate Resistant Prostate Cancer Enhertu Therapy

RECRUITINGPhase 2Sponsored by Washington D.C. Veterans Affairs Medical Center
Actively Recruiting
PhasePhase 2
SponsorWashington D.C. Veterans Affairs Medical Center
Started2025-03-05
Est. completion2027-10
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion 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

Exclusion Criteria:

* History of interstitial lung disease or pneumonitis requiring steroids
* Significant coronary vascular disease
* Previous exposure to HER2 targeted therapy

Conditions4

CRPCCancerProstate CancerProstate Cancer Metastatic

Locations1 site

Washington DC VAMC
Washington D.C., District of Columbia, 20422
Asha Escobar2027431090asha.escobar@Va.gov

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