Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

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.

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.

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