NCT00977860

Hypofractionated SBRT For Prostate Cancer

Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Adam Olson · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Detailed description

Radiosurgery should be ideal for treating prostate cancer because: * targeting accuracy for static targets is excellent, with an error of about 1mm, * it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs, * by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators, * the radiobiology of prostate cancer may favor large dose per fractions.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period

Timeline

• Start date: 2010-10-07
• Primary completion: 2022-07-08
• Completion: 2022-07-08
• First posted: 2009-09-16
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study