At a glance
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Phase II Trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) Plus Enzalutamide for the Treatment of Selected Patients With Metastatic Castration-Resistant Prostate Cancer (TraPPer)
In Brief
A Phase 2 clinical trial evaluating Biopsy, Biospecimen Collection, and 6 other interventions for Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8. Completed, enrolled 7 participants across 3 sites.
Signals
Detailed Summary
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows pertuzumab and trastuzumab to be given by injection under the skin and shortens their administration time compared to pertuzumab or trastuzumab alone. Chemotherapy drugs, such as enzalutamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide may kill more cancer cells.
Study Details
Timeline
Arms & Interventions
Patients receive pertuzumab, trastuzumab, and hyaluronidase-zzxf SC on day 1 of each cycle and enzalutamide PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, biopsy, CT, and MRI scans and collection of blood samples throughout the study.
Interventions
Undergo biopsy
Undergo collection of blood and tissue samples
Undergo CT
Undergo ECHO
Given PO
Given SC
Undergo MRI
Ancillary studies