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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

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).

Condition Intervention Phase
Prostate Cancer
Radiation: radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • To evaluate acute and long term tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer [ Time Frame: 5years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate local tumor control and biochemical progression-free and metastasis-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
prostate radiation to 70Gy, lymph nodes to 56Gy
Radiation: radiotherapy
prostate radiation to 70Gy; nodal radiation to 56Gy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00214136

United States, Wisconsin
University Of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Mark Ritter, MD, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214136     History of Changes
Other Study ID Numbers: RO04807, NCI-P01 CA88960
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration processed this record on March 31, 2015