PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer

Launched by ROBERT FLAVELL, MD, PHD · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to see how a specific protein called CD46 is expressed in men with advanced prostate cancer, particularly those whose cancer no longer responds to hormone therapy. The study uses a special imaging technique to help researchers understand if targeting CD46 could lead to better treatments for the most aggressive forms of prostate cancer. The information gathered from this trial may guide the development of new therapies that could improve outcomes for patients.

To participate in this study, men must be at least 18 years old and have been diagnosed with metastatic, castration-resistant prostate cancer. They should also be in good enough health to complete the trial and be able to understand and sign a consent form. If you join the trial, you can expect to undergo imaging tests that will help researchers gather important information about your cancer. It’s a chance to contribute to advancing treatments for prostate cancer and potentially improve care for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
• • 2. Age \>=18 years
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%).
• 4. Demonstrates adequate organ function as defined below:
• • 1. Total bilirubin \<1.5 X upper limit of normal (ULN).
• • 2. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \<= 3 X institutional upper limit of normal (ULN).
• • 3. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \<= 3 X institutional ULN.
• • 4. Serum creatinine \<=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) \>= 60 mL/min, calculated using the Cockcroft-Gault equation.
• • 5. Ability to understand a written informed consent document, and the willingness to sign it.
• • 6. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Exclusion Criteria:
• • 1. Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent.
• • 2. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.