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
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed, adenocarcinoma of the prostate

• T1-2N0M0 with risk of pelvic lymph nodes involvement \>25% by Roach formula \[(2/3xPSA) + (Gleason Score - 6)x10\], or any T3-4N0M0

• Karnofsky Performance Scale \> 70.

• Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.

• No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.

• Patients must sign a study-specific consent form prior to registration.

• No evidence of distant metastases (Bone scanning)

Locations
United States
Wisconsin
Froedtert & the Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2010-06-23
Completion Date: 2030-06-21
Participants
Target number of participants: 80
Treatments
Experimental: IMRT & IGRT Radiation Therapy
In this study we will deliver 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).
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov