Castrate Resistant Prostate Cancer Enhertu Therapy

Phase 2RecruitingNCT06610825

Washington D.C. Veterans Affairs Medical Center60 enrolled

Overview

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

This Phase II clinical trial aims to evaluate the efficacy and safety of Enhertu in HER-2 positive mCRPC who have progressed on prior androgen deprivation therapy and novel hormonal agents, who are either not candidates for or have refused taxane based chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi center study will include 60 participants treated with Enhertu. Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Metastatic Prostate Cancer CRPC

Interventions

EnhertuDRUG

This is an open label, multi-center, single arm, phase II study designed to investigate the anti-tumor activity, efficacy and safety of Enhertu in HER2-positive metastatic castrate-resistant prostate cancer patients who progressed on androgen deprivation therapy and novel hormonal agents (such as Abiraterone and Enzalutamide), who also progressed, refused, or were not candidates to receive taxane-based chemotherapy.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington DC VAMC

Washington D.C., District of Columbia, United States

RECRUITING

Outcomes

Primary Outcomes

ORR

Objective Response Rate by local review, combining radiographic and biochemical responses

Time frame: 2 years

Secondary Outcomes

Progression Free Survival

Time frame: 2 years

Overall Survival

Time frame: 2 years

Disease Control Rate

Time frame: 2 years

Duration of Response

Time frame: 2 years

Central Contacts

Asha Escobar

CONTACT

2027431090 asha.escobar@va.gov

Martha Antonio

CONTACT

martha.antonio@va.gov

Data from ClinicalTrials.gov

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