Clinical Trials Directory

Trials / Completed

CompletedNCT01664130

High-Dose Stereotactic Radiation for Prostate Cancer

High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue

Detailed description

PRIMARY OBJECTIVES: I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer. SECONDARY OBJECTIVES: I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores. II. Assess biochemical control after high-dose SBRT. OUTLINE: Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.

Conditions

Interventions

TypeNameDescription
RADIATIONstereotactic body radiation therapyUndergo SBRT
PROCEDUREquality-of-life assessmentAncillary studies
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2012-07-01
Primary completion
2017-01-12
Completion
2017-01-12
First posted
2012-08-14
Last updated
2020-05-21
Results posted
2019-09-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01664130. Inclusion in this directory is not an endorsement.