Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

Prostate Cancer Clinical Trial

Official title: RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Radiation Toxicity
• Sexual Dysfunction

• NCT number: NCT01856855
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: December 2022