NCT01856855

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: John Fiveash, MD · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy with Integrated Boost	SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions

Timeline

• Start date: 2013-02-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2013-05-17
• Last updated: 2023-01-12
• Results posted: 2023-01-12

Locations

1 site across 1 country: United States