Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214097
First received: September 13, 2005
Last updated: January 23, 2013
Last verified: January 2013
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate local tumor control and biochemical progression-free survival. [ Time Frame: 90 days post radiation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: August 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214097

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214097     History of Changes
Other Study ID Numbers: RO02803, NCI (P01 CA88960)
Study First Received: September 13, 2005
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014