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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.

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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.

Conditions Studied

Prostate Cancer

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

FieldValue
Enrollment Target 32 participants
Start Date 2013-04
Est. Completion 2020-12
Phase Phase 1

Sponsor

Timothy Showalter, MD

1 total trials

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What the Registry Record Tells You About NCT01868386

The ClinicalTrials.gov registry entry for NCT01868386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Timothy Showalter, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 1 distinct geographic area - top geographies include 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.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.