This pilot trial studies the side effects of ultra-hypofractionated radiation therapy, also known as stereotactic body radiation therapy, and how well it works in treating participants with early prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Further shortening the stereotactic body radiation therapy to 2 higher dose treatments, but lower total dose than standard treatment, may work better in treating participants with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03486821.
PRIMARY OBJECTIVE:
I. To demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the Expanded Prostate Cancer Index Composite (EPIC)-26 genitourinary (GU) domain patient reported outcome.
SECONDARY OBJECTIVES:
I. Biochemical control rate.
II. Radiation Therapy Oncology Group (RTOG) toxicity.
III. Financial toxicity of treatment.
EXPLORATORY OBJECTIVES:
I. Oxidative stress as a predictor of toxicity.
II. Blood banking will be obtained for future investigations.
OUTLINE:
Participants undergo stereotactic body radiation therapy (SBRT) over 2 fractions (2-5 days) for 10-20 minutes in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 4 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorXinglei Shen
