Study on Pertuzumab, Trastuzumab, Hyaluronidase-zzxf, and Enzalutamide for Treating Metastatic Castration-Resistant Prostate Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05730712

Provider View

This clinical trial is testing a combination of drugs, including pertuzumab, trastuzumab, hyaluronidase-zzxf, and enzalutamide, to see how well they work in treating prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs—pertuzumab, trastuzumab, hyaluronidase-zzxf, and enzalutamide—works in treating prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. Pertuzumab and trastuzumab are targeted therapies that attach to a protein called HER2 on cancer cells, blocking signals that help the cancer grow. Hyaluronidase helps these drugs stay in the body longer and allows them to be given by injection under the skin. Enzalutamide is a chemotherapy drug that stops cancer cells from growing and spreading. The study aims to see if this combination can kill more cancer cells.

Description

The main goal of this study is to see if the combination of pertuzumab, trastuzumab, hyaluronidase-zzxf, and enzalutamide can improve the response rate in patients with prostate cancer that has spread and is resistant to hormone therapy. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates. They will assess any side effects and how the treatment affects patients' quality of life. The study will also explore how certain biological markers in the body relate to treatment outcomes.

Participants will receive pertuzumab, trastuzumab, and hyaluronidase-zzxf by injection under the skin and take enzalutamide orally. They will undergo various tests, including heart scans, biopsies, and imaging scans, and provide blood and tissue samples for research.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer that is resistant to hormone therapy and has spread to other parts of the body.
  • Have measurable cancer as defined by specific criteria.
  • Have previously received certain hormone therapies like enzalutamide or abiraterone.
  • Be willing to provide written informed consent and return for follow-up visits.
  • Be able to complete questionnaires with or without assistance.
  • Agree to provide blood and tissue samples for research.
  • Have a specific blood marker level and good overall health as indicated by various blood tests and heart function.
  • Agree to use effective contraception if of childbearing potential or able to father a child.

Exclusion Criteria

  • Recent history of heart attack or severe heart failure.
  • Not fully recovered from previous treatments.
  • Have uncontrolled illnesses, infections, or psychiatric conditions that could interfere with the study.
  • Be immunocompromised or HIV positive and on antiretroviral therapy.
  • Be taking other investigational drugs for prostate cancer.
  • Have had a recent thromboembolic event.
  • Have serious heart conditions or uncontrolled high blood pressure.
  • Be pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential.
  • Have other active cancers within the last three years, except for certain skin or cervical cancers.
  • Have known allergies to the study drugs or their components.
  • Require medications that interfere with the study drugs.

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