Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 Antigen (PSA) less than 10 ng.ml within 180 days prior to registration
Exclusion Criteria
- •Prior or concurrent invasive malignancy
- •Evidence of distant metastasis
Arms & Interventions
Proton radiation therapy
Single arm
Intervention: Proton Radiation (Radiation)
Proton radiation therapy
Single arm
Intervention: Proton (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Jerry D. Slater, MD
Professor and Chair Department of Radiation Medicine
Loma Linda University