Castrate Resistant Prostate Cancer Enhertu Therapy
Recruiting · NCT06610825 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington D.C. Veterans Affairs Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Enhertu
What this trial is about
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Washington DC VAMC - Washington D.C., District of Columbia, United States