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89Zr-DFO-YS5 Imaging for Prostate Cancer

Phase 1
Recruiting
Research Sponsored by Robert Flavell, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky >60%)
Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is investigating a new drug, FOR46, that targets CD46 in prostate cancer. CD46 is a protein that is found on the surface of many types of cells, and is particularly common in adenocarcinoma and Small-cell neuroendocrine carcinoma (SCNC), which are two aggressive and deadly forms of prostate cancer. The goal of the trial is to see if FOR46 can be used to treat these aggressive forms of prostate cancer, and to help develop new treatments that improve outcomes for men with these types of cancer.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They should be fairly active (able to care for themselves) and have good organ function, including liver and kidneys. Men who've had other cancers might qualify if it doesn't affect this trial's safety or results.Check my eligibility
What is being tested?
The study is testing a new imaging agent called 89Zr-DFO-YS5 used in PET/CT or PET/MRI scans to see if it can identify a protein linked to aggressive prostate cancer. This could help develop new treatments targeting this protein.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the imaging process such as discomfort at the injection site, allergic reactions, or side effects from contrast agents used during PET/CT or PET/MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly self-sufficient and can carry out daily activities.
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My prostate cancer has spread and does not respond to hormone therapy.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average SUVmax (SUVmax-ave) (Cohort C & D)
Median SUVmax (Cohort C & D)
Optimal antibody dose for imaging using 89Zr-DFO-YS5 PET (Cohort B)
+2 more
Secondary outcome measures
Average organ uptake of 89Zr-DFO-YS5 (Cohort C & D)
Inter-participant heterogeneity (Cohort C & D)
Inter-tumoral heterogeneity (Cohort C & D)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort D: 89Zr-DFO-YS5, Optimal dose YS5 antibody, Multiple ScansExperimental Treatment4 Interventions
Participants will receive optimal dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a series of whole body PET scans performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. Participants in have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Group II: Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibodyExperimental Treatment4 Interventions
Participants receive optimal dose of YS5 antibody prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Group III: Cohort B: 89Zr-DFO-YS5, YS5 antibodyExperimental Treatment4 Interventions
Participants receive either a 20mg or 50mg dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. The optimal dose of unmodified YS5 antibody will be used in the following cohorts C & D. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.
Group IV: Cohort A: 89Zr-DFO-YS5Experimental Treatment3 Interventions
Participants receive one dose of 89Zr-DFO-YS5 up to 3 millicurie (mCi), and undergo a whole body PET performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. The optimized scan time will be used for imaging in cohorts B and C. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression.

Find a Location

Who is running the clinical trial?

Robert Flavell, MD, PhDLead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Prostate Cancer
10 Patients Enrolled for Prostate Cancer
United States Department of DefenseFED
858 Previous Clinical Trials
225,597 Total Patients Enrolled
37 Trials studying Prostate Cancer
5,531 Patients Enrolled for Prostate Cancer
Fortis Therapeutics, Inc.Industry Sponsor
3 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Prostate Cancer
36 Patients Enrolled for Prostate Cancer

Media Library

89Zr-DFO-YS5 Clinical Trial Eligibility Overview. Trial Name: NCT05245006 — Phase 1
Prostate Cancer Research Study Groups: Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibody, Cohort A: 89Zr-DFO-YS5, Cohort B: 89Zr-DFO-YS5, YS5 antibody, Cohort D: 89Zr-DFO-YS5, Optimal dose YS5 antibody, Multiple Scans
Prostate Cancer Clinical Trial 2023: 89Zr-DFO-YS5 Highlights & Side Effects. Trial Name: NCT05245006 — Phase 1
89Zr-DFO-YS5 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245006 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum cohort size for this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial was initially listed in March 18th 2022 and has been recently refreshed with new data as of March 29th 2022. 24 individuals will be accepted at 1 site for partaking in the study."

Answered by AI

Is the recruitment process of this research still open?

"Yes, the clinicaltrials.gov portal denotes that this investigation is actively enrolling participants. The study was initially published on March 18th 2022 and recently revised on March 29th 2022, with 24 patients required at one site."

Answered by AI

Has 89Zr-DFO-YS5 earned the regulatory endorsement of the FDA?

"Considering the limited evidence available, our team at Power has assigned 89Zr-DFO-YS5 a score of 1 on safety. This is because it's currently in Phase 1 trials and data supporting efficacy and safety are scarce."

Answered by AI

What is the core objective of this medical experiment?

"According to Fortis Therapeutics, Inc., the primary measure of this trial's success is Optimal antibody dose for imaging using 89Zr-DFO-YS5 PET (Cohort B) and it will be studied over an Up to 24 months period. Additionally, Adverse Events related to treatment are being documented descriptively utilizing CTCAE version 5.0; Average organ uptake of 89Zr-DFO-YS5 is estimated; and Tumor-to-background signal (Cohort C) median and range for intra-tumoral SUVmax within metastatic lesions will also be reported on"

Answered by AI
~11 spots leftby Dec 2025