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NCT01868386 · ClinicalTrials.gov registry record · Phase 1
Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate
A Phase 1 study of Prostate Cancer, sponsored by Timothy Showalter, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT01868386: Completed Phase 1 study of Prostate Cancer, sponsored by Timothy Showalter, MD.
NCT01868386 is a Phase 1 study of Prostate Cancer that has completed, run by Timothy Showalter, MD. The registered enrollment target is 32 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01868386, a Phase 1 study of Prostate Cancer, has completed, sponsored by Timothy Showalter, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study Summary
Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation. The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.
Primary Outcome
Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater
Conditions Studied
Interventions
- RADIATION Hypofractionated therapy
Study Locations (3)
Virginia
- University of Virginia Health System - Charlottesville
- Southwest Virginia Regional Cancer Center - Norton
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-04 |
| Est. Completion | 2020-12 |
| Phase | Phase 1 |
What the finished NCT01868386 record still lists
NCT01868386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionated therapy is the first listed.
NCT01868386 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01868386 about?
NCT01868386 is a clinical study titled "Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate". Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvag...
What is the current status of trial NCT01868386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-04. Estimated completion is 2020-12.
What conditions does trial NCT01868386 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01868386?
The interventions under investigation include: Hypofractionated therapy (RADIATION).
Who is sponsoring clinical trial NCT01868386?
This trial is sponsored by Timothy Showalter, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01868386 being conducted?
This trial has 3 study locations across Virginia. 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 NCT01868386's enrollment target sits among peer trials
32 566th of 735 higher than 159 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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