Trials / Completed
CompletedNCT00643617
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 307 (actual)
- Sponsor
- Accuray Incorporated · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.
Detailed description
In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues. The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | CyberKnife Stereotactic Radiosurgery - Low Risk | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate |
| RADIATION | CyberKnife Stereotactic Radiosurgery - Intermediate Risk | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally |
Timeline
- Start date
- 2007-10-22
- Primary completion
- 2022-04-07
- Completion
- 2022-04-07
- First posted
- 2008-03-26
- Last updated
- 2023-05-09
- Results posted
- 2023-05-09
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00643617. Inclusion in this directory is not an endorsement.