NCT06610825 · Washington D.C. Veterans Affairs Medical Center
Castrate Resistant Prostate Cancer Enhertu Therapy
(CaRPET)
What this study is about
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
View original scientific description
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Interventions
DRUG
Enhertu
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.
Primary outcome measures
ORR
Time frame: 2 years
Objective Response Rate by local review, combining radiographic and biochemical responses
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Washington D.C., District of Columbia
Collaborators
Daiichi Sankyo, Cancer Research And Biostatistics, Institute for Clinical Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations