Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer

Inclusion Criteria:

• Patient must give study-specific informed consent on an IRB-approved consent prior toany research related procedures or study treatment.
• Patient must be at least 18 years at the time of consent.
• Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease withhistological evaluation via biopsy or repeat biopsy within 12 months prior toregistration.
• Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3TTesla machine within 6 months prior to study registration.
• A focal IPT must be visible on MRI within the prostate and/or seminal vesicles andthis MRI must be obtained within 6 months of planning CT scan.
• A biopsy of the dominant lesion is recommended but not required. If an ultrasoundguided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRIidentified intraprostatic lesion, this will be acceptable and another guided biopsytargeting the MRI identified disease will not be necessary.
• Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage ofT3, Gleason score 8-10, or PSA 20 ng/ml or greater.
• Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
• Zubrod performance status must be 0-1 within 4 months prior to registration.
• If patient has child-producing potential, they must be willing to use medicallyacceptable contraception during treatment and must be advised to use it for at least 1year thereafter. This is not applicable if the patient is not sexually active or hashad a vasectomy.
• Patients must be able to start treatment within 16 weeks of registration.

Exclusion Criteria:

• T4 prostate disease on CT, MRI, or physical exam.
• Patients unable to undergo MRI of the prostate.
• Patients with a greater than 25% change in prostate volume from the pretreatment MRIof the prostate demonstrating the IPT and the treatment planning MRI. Patients in thiscase must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPTmust still be visible.
• IPT that is more than 75% of the prostate volume when measured on the CT simulationscan.
• Evidence of distant metastasis (M1).
• Patients with positive nodes on cross-sectional imaging.
• Previous prostate cancer local treatment including prostatectomy, hyperthermia, highintensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/orcryotherapy.
• Prior pelvic radiation therapy.
• No prior myocardial infarction within the last 6 months, severe congestive heartfailure, or end stage renal disease.
• Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerativecolitis) affecting the rectum.
• Bilateral hip replacement
• Prior intrapelvic surgery. This includes the following: • Bladder surgery
• Prior transurethral resection of the prostate (TURP) or laser ablation for benignprostatic hyperplasia (BPH).
• Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilatemesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa),enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/erdipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).