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NCT01618838 · ClinicalTrials.gov registry record · NA

Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

A NA study, sponsored by Georgetown University.

Terminated
Registry status
NA
Development phase
4
Enrollment target

NCT01618838: Clinical Trial NA study, sponsored by Georgetown University.

NCT01618838 is a NA study that was terminated before completion, run by Georgetown University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01618838, a NA study, was terminated before completion, sponsored by Georgetown University.

TERMINATED
Registry status
NA
Development phase
4 participants
Enrollment target

Study Summary

Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live with the side effects for many years. Attempts have been made to protect surrounding tissues while delivering high dosage of radiation to cancer. With the rectum being so close to the prostate, many patients still suffer from side effects caused by radiation injury to the rectum, especially those who received conventional external beam radiotherapy. CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation beams to be delivered in different directions, providing a highly conformal, uniform dose with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system should minimize the toxicity to the surrounding structures. CyberKnife System also incorporates a dynamic tracking system to allow the robot to correct the targeting of therapeutic beams during treatment. These improvements allow for dose escalation within the prostate with less normal tissue toxicity. The purpose of this study is to estimate the proportion of patients with endoscopically detectable telangiectasia as the indication of radiation injury to the rectum, after CyberKnife Treatment for prostate cancer.

Primary Outcome

Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome. No patients had outcome before the trial was terminated.

Interventions

  • RADIATION CyberKnife radiosurgery

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2011-02
Est. Completion 2012-12
Phase NA
Georgetown University

227 total trials

Why NCT01618838 stopped before completion

NCT01618838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which CyberKnife radiosurgery is the first listed.

NCT01618838 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01618838 about?

NCT01618838 is a clinical study titled "Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer". Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live with the side effects for many years. Attempts have been made to protect surrounding tissues while delivering high...

What is the current status of trial NCT01618838?

This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2011-02. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01618838?

The interventions under investigation include: CyberKnife radiosurgery (RADIATION).

Who is sponsoring clinical trial NCT01618838?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01618838's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT01618838, the US trial registry maintained by the National Library of Medicine. NCT01618838 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.