ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-18

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05245006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Robert Flavell, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Robert Flavell, MD, PhD

Robert Flavell, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-18

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-03-18

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

First-in-Human
immunoPET agent
CD46 positive malignancy

Additional Relevant MeSH Terms

Prostate Cancer
Metastatic Castration-resistant Prostate Cancer