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Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

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: NCT00214097
Recruitment Status : Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : October 20, 2017
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 of using IMRT combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radiotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
Study Start Date : August 2002
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: dose escalation
3 cohorts of dose escalations
Procedure: Radiotherapy
Daily radiation to prescribed dose

Primary Outcome Measures :
  1. To evaluate acute and long term tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of IMRT, daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate [ Time Frame: 90 days post radiation ]

Secondary Outcome Measures :
  1. Evaluate local tumor control and biochemical progression-free survival. [ Time Frame: 90 days post radiation ]

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

Inclusion Criteria:

  • Prostate Cancer stage 2b or less, predicted risk of lymph node involvement less then 15%, Gleason <7, No distance mets

Exclusion Criteria:

  • distant mets

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): NCT00214097

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)
Principal Investigator: Mark Ritter, MD, PhD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214097     History of Changes
Other Study ID Numbers: RO02803
NCI (P01 CA88960)
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

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