Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: radiotherapy

• Registration Number: NCT00214136
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-08-08
• Results First Submitted QC: 2017-09-11
• Results First Posted: 2017-10-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Prostate cancer stage T-T3
• Predicted risk of lymph node involvement > 15%
• Gleason > 7

Exclusion Criteria

• Distance metastases
• Use of anti-coagulant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	radiotherapy	prostate radiation to 70Gy, lymph nodes to 56Gy

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Expected Toxicities	Up to 5 years	Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.

Secondary Outcome Measures

Name	Time	Method
To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival	5 years	Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.

Trial Locations

Locations (1)

University Of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States