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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiation Therapy

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Clinical or pathological evidence of distant metastases (M1).
• Radical surgery for carcinoma of the prostate
• History of prior chemotherapy
• History of prior pelvic radiation therapy
• Children (age < 18).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).; Other Names: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	4 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	7 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	10 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	13 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	16 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	19 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	22 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	25 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	31 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	37 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	43 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	49 months
Change from baseline PSA level	PSA level in blood is measured in units of nanograms per milliliter.	55 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	4 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	7 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	10 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	13 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	16 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	19 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	22 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	25 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	31 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	37 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	43 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	49 months
PSA level	PSA level in blood is measured in units of nanograms per milliliter.	55 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: William Hall, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2010
• Primary Completion (Actual): March 2, 2026
• Study Completion (Estimated): August 17, 2026

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (Estimated): June 27, 2014

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Radiotherapy, Intensity-Modulated; Radiotherapy, Image-Guided
• Other Study ID Numbers: PRO00013374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No