A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
• Patient age greater than or equal 18
• Localized adenocarcinoma of the prostate
• Biopsy-proven diagnosis of prostate adenocarcinoma
• Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
‣ TX-T2c-8th addition staging
⁃ PSA\<20 ng/ml
⁃ Grade group 3 or less
• Proper rectal space replacement required as determined by the treating radiation oncologist
• Prostate size less than 60cc defined at time of simulation based on MRI
• Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
• \-- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
• Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
• Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
• Ability to give informed consent