Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT02177292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2014-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIB
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: