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89Zr-DFO-YS5 Imaging for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am mostly self-sufficient and can carry out daily activities.I have previously received the YS5 antibody.My prostate cancer has spread and does not respond to hormone therapy.I am unable to give informed consent due to my age, health, or mental condition.I am 18 years old or older.
- Group 1: Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibody
- Group 2: Cohort A: 89Zr-DFO-YS5
- Group 3: Cohort B: 89Zr-DFO-YS5, YS5 antibody
- Group 4: Cohort D: 89Zr-DFO-YS5, Optimal dose YS5 antibody, Multiple Scans
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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"
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