Ultra-Hypofractionated Radiation Therapy in Treating Participants with Early Prostate Cancer
- Ability of participant to sign a written informed consent
- Diagnosed with prostate cancer, T1-T2bN0M0 Gleason score (GS) 6-7; prostate specific antigen (PSA) < 20
- International Prostate Symptom Score (IPSS) < 18 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment
- Prostate volume (by ultrasound [US], computed tomography [CT] or magnetic resonance imaging [MRI] measurement) < 60 cc at time of enrollment
- Androgen deprivation therapy based on clinician judgment is permitted on study
- Life expectancy > 10 years based on clinician’s judgment
- No other active malignancy
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Other study-specific criteria: * Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment; ** NOTE: Acceptable forms of birth control are listed below: *** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS *** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
- Current or anticipated use of other investigational agents while participating in this study
- Psychiatric illness/social situations that would limit compliance with study requirements
- Prior pelvic radiation therapy
- Prior prostatectomy
- Inflammatory bowel disease or connective tissue disease requiring medical management
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.
I. Biochemical control rate.
II. Radiation Therapy Oncology Group (RTOG) toxicity.
III. Financial toxicity of treatment.
I. Oxidative stress as a predictor of toxicity.
II. Blood banking will be obtained for future investigations.
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 Phase Phase NA
Trial Type Treatment
University of Kansas Cancer Center
- Primary ID STUDY00141963
- Secondary IDs NCI-2018-00782
- Clinicaltrials.gov ID NCT03486821