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NCT05588128 · ClinicalTrials.gov registry record
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
A clinical trial of Prostate Cancer and Biochemically Recurrent, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 350
- Enrollment target
- 1
- Study location
NCT05588128: Recruiting study of Prostate Cancer and Biochemically Recurrent, sponsored by National Cancer Institute (NCI).
NCT05588128 is a study of Prostate Cancer and Biochemically Recurrent that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 350 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05588128, a study of Prostate Cancer and Biochemically Recurrent, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 350 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years.
Primary Outcome
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Conditions Studied
Interventions
- DRUG 18F-DCFpyL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2027-12-31 |
What NCT05588128 shows while recruiting
NCT05588128 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 18F-DCFpyL is the first listed.
NCT05588128 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05588128 about?
NCT05588128 is a clinical study titled "Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL". Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural hist...
What is the current status of trial NCT05588128?
This trial is currently recruiting. The enrollment target is 350 participants. The study started on 2023-03-21. Estimated completion is 2027-12-31.
What conditions does trial NCT05588128 study?
This clinical trial studies the following conditions: Prostate Cancer, Biochemically Recurrent.
What interventions are being tested in trial NCT05588128?
The interventions under investigation include: 18F-DCFpyL (DRUG).
Who is sponsoring clinical trial NCT05588128?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05588128 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05588128's enrollment target sits among peer trials
350 146th of 735 higher than 588 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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