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RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.
Objectives: Primary -Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer Secondary * Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer * Determine the treatment planning and dosimetric feasibility * Evaluate the treatment delivery quality assurance * Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer Patients will undergo 5 total radiation treatments over 7-17 day period. Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2. After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.
Age
19 - No limit years
Sex
MALE
Healthy Volunteers
No
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, United States
Start Date
February 1, 2013
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2022
Last Updated
January 12, 2023
26
ACTUAL participants
Stereotactic Body Radiation Therapy with Integrated Boost
RADIATION
Lead Sponsor
John Fiveash, MD
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04550494