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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214136
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : October 12, 2017
Last Update Posted : December 2, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1
prostate radiation to 70Gy, lymph nodes to 56Gy
Radiation: radiotherapy
prostate radiation to 70Gy; nodal radiation to 56Gy

Primary Outcome Measures :
  1. Number of Participants Experiencing Expected Toxicities [ Time Frame: 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 :
  1. To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival [ Time Frame: 5 years ]
    Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214136

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United States, Wisconsin
University Of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
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Principal Investigator: Mark Ritter, MD, PhD University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00214136    
Other Study ID Numbers: RO04807
P01CA088960 ( U.S. NIH Grant/Contract )
H-2004-0472 ( Other Identifier: Institutional Review Board )
NCI-2011-00947 ( Registry Identifier: NCI Trial ID )
A533300 ( Other Identifier: UW Madison )
SMPH\HUMAN ONCOLOGY ( Other Identifier: UW Madison )
First Posted: September 21, 2005    Key Record Dates
Results First Posted: October 12, 2017
Last Update Posted: December 2, 2019
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases