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NCT00547339 · ClinicalTrials.gov registry record · Phase 1

Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
Phase 1
Development phase
94
Enrollment target

NCT00547339: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.

NCT00547339 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 94 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00547339, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
94 participants
Enrollment target

Study Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.

Primary Outcome

Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)

Interventions

  • RADIATION stereotactic body radiation therapy (SBRT)- 45 Gy
  • RADIATION stereotactic body radiation therapy (SBRT) - 47.5 Gy
  • RADIATION stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
  • RADIATION stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2006-07
Est. Completion 2022-11-28
Phase Phase 1

What the finished NCT00547339 record still lists

NCT00547339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).

The record links to 0 conditions, and to 4 interventions - of which stereotactic body radiation therapy (SBRT)- 45 Gy is the first listed.

NCT00547339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00547339 about?

NCT00547339 is a clinical study titled "Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer". RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients ...

What is the current status of trial NCT00547339?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2006-07. Estimated completion is 2022-11-28.

What interventions are being tested in trial NCT00547339?

The interventions under investigation include: stereotactic body radiation therapy (SBRT)- 45 Gy (RADIATION), stereotactic body radiation therapy (SBRT) - 47.5 Gy (RADIATION), stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) (RADIATION), stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) (RADIATION).

Who is sponsoring clinical trial NCT00547339?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00547339's enrollment target sits among peer trials

94 615th of 2000 higher than 1,377 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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Source: ClinicalTrials.gov NCT00547339, the US trial registry maintained by the National Library of Medicine. NCT00547339 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.