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NCT05245006 · ClinicalTrials.gov registry record · Phase 1
PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer
A Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Robert Flavell, MD, PhD.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05245006: Active Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Robert Flavell, MD, PhD.
NCT05245006 is a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by Robert Flavell, MD, PhD. The registered enrollment target is 30 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05245006, a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by Robert Flavell, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
For Cohort A, the optimal time point will be selected based on optimal maximun Standardized uptake value (SUVmax) of metastatic lesions, and ratio of SUVmax to blood pool. Due to the limited samples, the investigator will use all available lesions without considering the location of the lesions or the possible intra-correlation of the lesions from the same participant.
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography (PET)/Computerized tomography (CT)
- DRUG 89Zr-DFO-YS5
- BIOLOGICAL YS5 antibody
- PROCEDURE Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What the registry record for NCT05245006 still lists
NCT05245006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Positron Emission Tomography (PET)/Computerized tomography (CT) is the first listed.
NCT05245006 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05245006 about?
NCT05245006 is a clinical study titled "PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer". 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 ...
What is the current status of trial NCT05245006?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-03-18. Estimated completion is 2027-07-31.
What conditions does trial NCT05245006 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT05245006?
The interventions under investigation include: Positron Emission Tomography (PET)/Computerized tomography (CT) (PROCEDURE), 89Zr-DFO-YS5 (DRUG), YS5 antibody (BIOLOGICAL), Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) (PROCEDURE).
Who is sponsoring clinical trial NCT05245006?
This trial is sponsored by Robert Flavell, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05245006 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05245006's enrollment target sits among peer trials
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