NCT02177292

High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Detailed description

In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate. It is hoped that these newer technologies will: 1. allow a higher daily dose of radiation to the tumor and pelvic nodes 2. avoid nearby normal tissue and organs like the rectum and bladder 3. prevent the cancer from spreading or coming back

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

Timeline

• Start date: 2010-06-23
• Primary completion: 2026-04-01
• Completion: 2030-06-21
• First posted: 2014-06-27
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study