Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Proton Radiation; Radiation: Proton

• Registration Number: NCT00831623
• Lead Sponsor: Loma Linda University

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.

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 Timeline

• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Study Start: 2009-02-17
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Results First Submitted: 2021-06-15
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Results First Posted: 2023-03-13
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 167

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiation therapy	Proton	Single arm
Proton radiation therapy	Proton Radiation	Single arm

Primary Outcome Measures

Name	Time	Method
Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center / James M. Slater Proton Treatment Center; 🇺🇸 Loma Linda, California, United States