Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

This study is currently recruiting participants.
Verified March 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Jerry D. Slater, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00831623
First received: January 28, 2009
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.


Condition Intervention Phase
Prostate Cancer
Radiation: Proton Radiation
Radiation: Proton
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • To determine if late RTOG greater than and equal to Grade 3 treatment-related morbidity, no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule [ Time Frame: yearly update ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the incidence of acute and late GI and GU morbidity [ Time Frame: yearly update ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 105
Study Start Date: March 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton radiation therapy Radiation: Proton Radiation
3 CGE/Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)
Radiation: Proton
The Rx is 3 CGE/Day to isocenter, one treatment per day, 5 days per week, for 20 treatments (=60 CGE to isocenter/20 fractions)

Detailed Description:

Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma within 180 days of registration
  • History & Physical Exam, including DRE, within 8 wks prior to registration
  • Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
  • Clinical stage T1-T2C
  • PSA less than 10 ng.ml within 180 days prior to registration

Exclusion Criteria:

  • Prior or concurrent invasive malignancy
  • Evidence of distant metastasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831623

Locations
United States, California
Loma Linda University Medical Center / James M. Slater Proton Treatment Center Recruiting
Loma Linda, California, United States, 92354
Contact: Jerry D Slater, MD    909-558-4258    jdslater@dominion.llumc.edu   
Principal Investigator: Jerry D Slater         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Jerry D Slater, MD Loma Linda University Medical Center Dept. of Radiation Medicine
  More Information

Publications:
Responsible Party: Jerry D. Slater, MD, Professor and Chair Department of Radiation Medicine, Loma Linda University
ClinicalTrials.gov Identifier: NCT00831623     History of Changes
Other Study ID Numbers: 58116
Study First Received: January 28, 2009
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
hypofractionation
proton beam radiation

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 April 17, 2014