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NCT03253744 · ClinicalTrials.gov registry record · Phase 1
Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03253744: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03253744 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03253744, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT). Objective: To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation. Eligibility: Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease. Design: Participants will be screened with blood tests, physical exam, and medical history. They may also have: Magnetic resonance imaging (MRI) scan of the prostate. Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table. Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation. About 2 weeks later, participants will have a radiation treatment planning CT scan. Participants will answer questions about their urine function, bowel function, erectile function, and mood. Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks. Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires. Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated. Participants will continue to have routine visits until two years after treatment is completed....
Interventions
- DRUG 18F-DCFPyL
- RADIATION Tumor Irradiation
- RADIATION Prostate + tumor irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253744
The ClinicalTrials.gov registry entry for NCT03253744 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 18F-DCFPyL is the first listed.
NCT03253744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03253744 about?
NCT03253744 is a clinical study titled "Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy". Background: Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is g...
What is the current status of trial NCT03253744?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-07-05. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT03253744?
The interventions under investigation include: 18F-DCFPyL (DRUG), Tumor Irradiation (RADIATION), Prostate + tumor irradiation (RADIATION).
Who is sponsoring clinical trial NCT03253744?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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