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Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT00831623
Collaborator
(none)
166
Enrollment
1
Location
1
Arm
124.6
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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 Phase
  • Radiation: Proton Radiation
  • Radiation: Proton
 N/A

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
Actual Enrollment :
166 participants
Allocation:
N/A
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 :
Mar 1, 2009
Actual Primary Completion Date :
Jul 18, 2019
Actual Study Completion Date :
Jul 18, 2019

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 Names:
  • Proton Radiation treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment-related morbidity [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 [yearly update greater than 20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Medical Center / James M. Slater Proton Treatment Center Loma Linda California United States 92354

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

    • Principal Investigator: Jerry D Slater, MD, Loma Linda University Medical Center Dept. of Radiation Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jerry D. Slater, MD, Professor and Chair Department of Radiation Medicine, Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT00831623
    Other Study ID Numbers:
    • 58116
    First Posted:
    Jan 29, 2009
    Last Update Posted:
    Feb 6, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Jerry D. Slater, MD, Professor and Chair Department of Radiation Medicine, Loma Linda University
    hypofractionation
    proton beam radiation
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Feb 6, 2020