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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation Therapy

• Registration Number: NCT02177292
• Lead Sponsor: Medical College of Wisconsin

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

Study Timeline

• Study Start: 2010-06-23
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-06-22
• Study Completion: 2030-06-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT & IGRT Radiation Therapy	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline PSA level	55 months	PSA level in blood is measured in units of nanograms per milliliter.

Trial Locations

Locations (1)

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States