Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00831623
First received: January 28, 2009
Last updated: August 20, 2015
Last verified: August 2015
  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:
  • Treatment-related morbidity [ Time Frame: yearly update ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: June 2025
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton radiation therapy 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
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 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
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: 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: Loma Linda University
ClinicalTrials.gov Identifier: NCT00831623     History of Changes
Other Study ID Numbers: 58116
Study First Received: January 28, 2009
Last Updated: August 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
hypofractionation
proton beam radiation

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

ClinicalTrials.gov processed this record on September 03, 2015