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Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00214097
First Posted: September 21, 2005
Last Update Posted: October 20, 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 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 Intervention Phase
Prostate Cancer Procedure: Radiotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

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

Enrollment: 309
Study Start Date: August 2002
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose escalation
3 cohorts of dose escalations
Procedure: Radiotherapy
Daily radiation to prescribed dose

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

Exclusion Criteria:

  • distant mets
  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): NCT00214097


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: NCT00214097     History of Changes
Other Study ID Numbers: RO02803
NCI (P01 CA88960)
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 20, 2017
Last Verified: October 2017

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