Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

This is a single arm clinical program designed to establish and quantify the rates of long-term toxicities and tumor control of a hypo-fractionated course of radiotherapy for the treatment of low-risk localized prostate cancer. Hypo-fractionated radiotherapy is an accelerated radiotherapy course where fewer but larger daily doses of radiotherapy are given. When an image-guided conformal radiotherapy technique is used to deliver hypo-fractionated radiotherapy it is often also called stereotactic body radiotherapy (SBRT).

Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).

Inclusion Criteria:

• Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
• The ability to understand and willingness to sign a written informed consent are necessary.

Exclusion Criteria:

• Patients with tumor parameters that fall outside of the inclusion criteria.
• Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
• Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
• A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
• The use of other concurrent investigational agents.
• There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
• No life expectancy restrictions will apply.
• Performance status will not be considered.