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NCT03388619 · ClinicalTrials.gov registry record · Phase 1
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03388619: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03388619 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03388619, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Scan that uses a small amount of radiation to make a picture of the body * Scan that uses a magnetic field to make an image of the body * Participants will provide documents that confirm their diagnosis. * Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Primary Outcome
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days
Interventions
- DIAGNOSTIC_TEST CT
- RADIATION Prostate bed with integrated boost
- RADIATION Prostate bed irradiation only
- DIAGNOSTIC_TEST Whole Body Bone Scan
- DIAGNOSTIC_TEST 18F-NaF PET Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 1 |
What the finished NCT03388619 record still lists
NCT03388619 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which CT is the first listed.
NCT03388619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03388619 about?
NCT03388619 is a clinical study titled "Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy". Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a s...
What is the current status of trial NCT03388619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-01-17. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT03388619?
The interventions under investigation include: CT (DIAGNOSTIC_TEST), Prostate bed with integrated boost (RADIATION), Prostate bed irradiation only (RADIATION), Whole Body Bone Scan (DIAGNOSTIC_TEST), 18F-NaF PET Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03388619?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03388619's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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