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NCT05155046 · ClinicalTrials.gov registry record · Phase 2
18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy
A Phase 2 study of Localized Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT05155046: Recruiting Phase 2 study of Localized Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT05155046 is a Phase 2 study of Localized Prostate Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 130 participants, above the 96-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (35% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155046, a Phase 2 study of Localized Prostate Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment. Eligibility: People ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT). Design: Participants will be screened with: Medical history Physical exam Blood tests MRI Participants will have baseline MRI and PET/CT scans. For the MRI, they may get a contrast agent by IV injection. For the PET/CT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET/CT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study. Participants will get SBRT with or without ADT. Participants will complete questionnaires about their quality of life. Participants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam. Participants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past. After treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.
Primary Outcome
For the purpose of this study, the imaging response to treatment will be categorized separately in the radiation treatment volume (in field; local) and distantly (outside the radiation treatment volume). In-field (in the radiation target volume) 18F-DCFPyL PET/CT treatment response in field will be evaluated using a descriptor (complete, partial, progression) based on maximum SUV and volume of uptake relative to the pre-treatment imaging. Presence of new areas of uptake suspicious for prostate c
Conditions Studied
Interventions
- DRUG 18F-DCFPyL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT05155046 shows while recruiting
NCT05155046 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Localized Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which 18F-DCFPyL is the first listed.
NCT05155046 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05155046 about?
NCT05155046 is a clinical study titled "18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy". Background: Identifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help. Objective: To test how an imaging agent called 18F-DCFPyL detects response to standard pro...
What is the current status of trial NCT05155046?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2022-08-31. Estimated completion is 2029-12-31.
What conditions does trial NCT05155046 study?
This clinical trial studies the following conditions: Localized Prostate Cancer.
What interventions are being tested in trial NCT05155046?
The interventions under investigation include: 18F-DCFPyL (DRUG).
Who is sponsoring clinical trial NCT05155046?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05155046 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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