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NCT06610825 | RECRUITING | Prostate Cancer Metastatic

Castrate Resistant Prostate Cancer Enhertu Therapy
Sponsor:

Washington D.C. Veterans Affairs Medical Center

Brief Summary:

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

Condition or disease

Prostate Cancer Metastatic

Prostate Cancer

CRPC

Intervention/treatment

Enhertu

Phase

PHASE2

Detailed Description:

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
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-03-05
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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
Castrate Resistant Prostate Cancer Enhertu Therapy

Location Details

NCT06610825

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Locations

RECRUITING

United States, District of Columbia

Washington DC VAMC

Washington DC, District of Columbia, United States, 20422