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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214136
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 30
Study Start Date: March 2005
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00214136


Locations
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)
Investigators
Principal Investigator: Mark Ritter, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214136     History of Changes
Other Study ID Numbers: RO04807
NCI-P01 CA88960
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: August 8, 2017
Results First Posted: October 12, 2017
Last Update Posted: October 12, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases