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NCT05678322 · ClinicalTrials.gov registry record · Phase 3
Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
A Phase 3 study of Prostate Cancer, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05678322 is a Phase 3 study of Prostate Cancer that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 26 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05678322, a Phase 3 study of Prostate Cancer, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA \> 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease recurrence. Early identification of the site(s) of disease recurrence enables early salvage intervention. Men will be eligible for the study at the point in time their post-prostatectomy PSA level first becomes \>0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable disease (local, nodal or systemic) will be offered salvage intervention per standard of care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA is \> 0,5 ng/ml or one year after the initial PET study. The salvage interventions will be at the discretion of the investigator. The study will compare the diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.
Conditions Studied
Interventions
- DRUG 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent
- DEVICE PET MRI Imaging
Study Locations (1)
New York
- Smilow Comprehensive Prostate Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2025-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05678322
The ClinicalTrials.gov registry entry for NCT05678322 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent is the first listed.
NCT05678322 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05678322 about?
NCT05678322 is a clinical study titled "Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy". All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA \> 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidenc...
What is the current status of trial NCT05678322?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2023-01-31. Estimated completion is 2025-11.
What conditions does trial NCT05678322 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05678322?
The interventions under investigation include: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent (DRUG), PET MRI Imaging (DEVICE).
Who is sponsoring clinical trial NCT05678322?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05678322 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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