Imaging study using a novel agent in men with prostate cancer

A First-in-Human, Pilot PET Imaging Study of 89Zr-DFO-YS5, an immunoPET Agent for Detecting CD46 Positive Malignancy in Men With Prostate Cancer

This study is testing a new imaging agent in men with advanced prostate cancer to see if it can better detect cancer spread compared to standard imaging methods.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05245006 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the use of a novel imaging agent, 89Zr-DFO-YS5, in men diagnosed with metastatic castration-resistant prostate cancer (mCRPC). Participants will undergo up to four PET imaging sessions to assess the optimal timing and dosage for imaging, as well as the agent's ability to detect metastatic lesions compared to conventional imaging methods. The study also seeks to gather data on the safety and organ uptake of the imaging agent, which could inform future therapeutic developments targeting CD46 in prostate cancer. The findings may help improve treatment outcomes for patients with aggressive forms of the disease.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed metastatic castration-resistant prostate cancer.

Not a fit: Patients with non-castration-resistant prostate cancer or those with significant comorbidities affecting organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques that enhance the detection and treatment of lethal prostate cancer forms.

How similar studies have performed: Other studies have shown promise in using novel imaging agents for cancer detection, but this specific approach targeting CD46 is relatively novel.

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Robert Flavell, MD, PhD — University of California, San Francisco
• Study coordinator: Maya Aslam

Conditions Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; First-in-Human; immunoPET agent; CD46 positive malignancy