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

Running, not enrolling · Phase 1

Conditions studied: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer

In brief

CD46 is an exciting new therapeutic target in prostate cancer, with the antibody drug conjugate FOR46 under investigation in phase I clinical trials. The hypothesis of the study is that CD46 expression, measured via our novel imaging biomarker, is a characteristic feature of mCRPC, and particularly common in the most lethal forms of the disease including adenocarcinoma and Small-cell neuroendocrine carcinoma (SCNC). These data will provide crucial information about the feasibility of targeting cluster of differentiation 46 (CD46) in mCRPC, will be used guide the development of novel therapeutic and theranostic agents, to help develop treatments that improve outcomes for men with the most lethal forms of prostate cancer.

Key facts

Study ID

NCT05245006

Run by

Robert Flavell, MD, PhD

People needed

30

Starts

2022-03-18

Expected to finish

2027-07-31

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC).
• Age >=18 years
• Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >60%).
• Demonstrates adequate organ function as defined below:
• Total bilirubin <1.5 X upper limit of normal (ULN).
• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) <= 3 X institutional upper limit of normal (ULN).
• Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) <= 3 X institutional ULN.
• Serum creatinine <=1,5 X institutional ULN or calculated creatinine clearance (Glomerular filtration rate (GFR)) >= 60 mL/min, calculated using the Cockcroft-Gault equation.
• Ability to understand a written informed consent document, and the willingness to sign it.
• 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.

You may not qualify if…

• Patients who because of age, general medical, or psychiatric condition, or physiologic status cannot give valid informed consent.
• Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.