Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
167 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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