Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

February 14, 2023 updated by: Jerry D. Slater, MD, Loma Linda University

Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center / James M. Slater Proton Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Antigen (PSA) less than 10 ng.ml within 180 days prior to registration

Exclusion Criteria:

  • Prior or concurrent invasive malignancy
  • Evidence of distant metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
Time Frame: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years
To determine if late CTCAE version 4.0 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.
Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0
Time Frame: Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years
To determine if late CTCAE version 4.0 Grade 2 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.
Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2009

Primary Completion (Actual)

July 18, 2019

Study Completion (Actual)

July 18, 2019

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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