Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer - Full Text View

Sponsor:	Loma Linda University
Information provided by:	Loma Linda University
ClinicalTrials.gov Identifier:	NCT00831623

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-Risk Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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:	February 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

3 CGE/Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)

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

Contacts

Contact: Carl J Rossi, MD

909-558-4257

crossi@dominion.llumc.edu

Locations

United States, California
Loma Linda University Medical Center / James M. Slater Proton Treatment Center	Recruiting
Loma Linda, California, United States, 92354
Contact: Carl J Rossi, MD 909-558-4257 cjrossi@dominion.llumc.edu
Principal Investigator: Carl J Rossi, MD

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator:	Carl J Rossi, MD	Loma Linda University Department of Radiation Medicine
Study Chair:	Jerry D Slater, MD	Loma Linda University Medical Center Dept. of Radiation Medicine

More Information

Publications:

Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9.

Rossi CJ Jr, Slater JD, Yonemoto LT, Jabola BR, Bush DA, Levy RP, Grove R, Slater JM. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004 Oct;64(4):729-32.

Slater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52.

Responsible Party:	Loma Linda University Dept. of Radiation Medicine ( Carl J. Rossi, MD )
Study ID Numbers:	58116
Study First Received:	January 28, 2009
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00831623 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:

hypofractionation
proton beam radiation

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009