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Trial record 7 of 1080 for:    prostate cancer AND radiation

Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00831623
Recruitment Status : Recruiting
First Posted : January 29, 2009
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Prostate Cancer Radiation: Proton Radiation Radiation: Proton

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer
Study Start Date : March 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Proton radiation therapy
Single arm
Radiation: Proton Radiation
3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)
Radiation: Proton
As above
Other Name: Proton Radiation treatment

Outcome Measures

Primary Outcome Measures :
  1. Treatment-related morbidity [ Time Frame: yearly update greater than 20 years ]
    To determine if late Radiation Therapy Oncology Group (RTOG) >/= to Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule

Secondary Outcome Measures :
  1. To determine the incidence of acute and late Gastrointestinal and To determine the incidence of acute and late gastrointestinal and genitourinary morbidity [ Time Frame: yearly update greater than 20 years ]

Eligibility Criteria

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:

  • Histologically confirmed adenocarcinoma within 180 days of registration
  • History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
  • Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
  • Clinical stage, Tumor Stage (T1-T2C)
  • Prostatic Specific Angigen (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

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): NCT00831623

Contact: *Jerry D Slater/Judy Hansen *PI 909-558-4258
Contact: Brooke Lawson, RN 1 800 496-4966 blawson@llu.edu

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@llu.edu   
Contact: Proton Referral Office, RN    1 800 496-4966      
Principal Investigator: Jerry D Slater         
Sponsors and Collaborators
Loma Linda University
Principal Investigator: Jerry D Slater, MD Loma Linda University Medical Center Dept. of Radiation Medicine
More Information

Slater JD. Twenty years of proton radiation therapy at Loma Linda University Medical Center. In U. Linz, editor. Ion beam therapy: fundamentals, technology, clinical applications. Berlin: Springer, 2012:581-595.

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
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Jerry D. Slater, MD, Loma Linda University:
proton beam radiation

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