Study on Enfortumab Vedotin as a Single Treatment for Metastatic Castration-Resistant Prostate Cancer

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04754191

Provider View

This clinical trial is testing the effectiveness of enfortumab vedotin, a new cancer treatment, in patients with metastatic castration-resistant prostate cancer. The study will start with enfortumab alone, and may include other drug combinations in the future.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the anti-tumor effects of enfortumab vedotin, a new cancer drug, in patients with metastatic castration-resistant prostate cancer. Initially, the trial will focus on enfortumab as a single treatment, but additional treatment combinations may be explored as they are identified.

Eligibility Criteria

Inclusion Criteria

  • Male, 18 years or older.
  • Confirmed diagnosis of prostate cancer that is not small cell type.
  • Cancer has spread or is advanced and cannot be surgically removed.
  • Low testosterone levels (below 50 ng/dL).
  • Previously treated with at least three cycles of taxane chemotherapy (such as docetaxel or cabazitaxel).
  • Previously treated with at least one novel hormone therapy (e.g., abiraterone, enzalutamide).
  • Have tried or refused other treatments known to improve survival, as recommended by guidelines.
  • Cancer has worsened after hormone therapy.
  • Good overall health with an ECOG score of 0 to 2.
  • Adequate blood and organ function, including:
    • White blood cells ≥ 2000/mm3
    • Neutrophils ≥ 1500/mm3
    • Platelets ≥ 100,000/mm3
    • Hemoglobin ≥ 9g/dL
    • Liver and kidney function within specified limits
  • Use effective birth control during the study.
  • Stopped all previous cancer treatments (except hormone therapy) at least 28 days before starting the study.
  • Recovered from side effects of previous treatments.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have another type of cancer besides prostate cancer.
  • Have a serious illness that would make participating unsafe.
  • Have significant heart disease, such as recent heart attack or severe heart failure.
  • Have HIV with a detectable viral load (unless controlled with treatment).
  • Have active hepatitis B or C with a detectable viral load.
  • Have received live vaccines within 4 weeks before starting the study.
  • Have severe allergies to the study drug or similar medications.
  • Taking medications that are not allowed during the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.