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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00214136

RO04807

H-2004-0472 (Other Identifier)

A533300 (Other Identifier)

SMPH\HUMAN ONCOLOGY (Other Identifier)

NCI-2011-00947 (Registry Identifier)

P01CA088960 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

prostate radiation to 70Gy, lymph nodes to 56Gy

Treatment:

Radiation: radiotherapy