Castrate Resistant Prostate Cancer Enhertu Therapy
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
About This Trial
- This clinical trial is testing a targeted drug called Enhertu for people with advanced prostate cancer that has spread and is no longer responding to standard hormone treatments.
- It is designed specifically for patients whose cancer cells test positive for a protein called HER2.
- Before joining, a sample of your tumor tissue must be tested to confirm HER2 is present, and you will need to continue your current hormone-blocking therapy.
- You should also be in fairly good daily health with normal heart and lung function, and have no history of severe lung problems or prior treatment with HER2-targeted drugs.
More Information
- Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing a targeted drug called Enhertu for people with advanced prostate cancer that has spread and is no longer responding to standard hormone treatments.
Study Details
- Start Date: March 5, 2025
- Lead Sponsor: Washington D.C. Veterans Affairs Medical Center
Full Eligibility 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
Treatments
- Drug: Enhertu