The primary objective of this study is to demonstrate that ultra-hypofractionation of
prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain
patient reported outcome.
- Ability of participant to sign a written informed consent.
- Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA < 20
- IPSS score < 18 (and < 10 if on medication for benign prostatic hypertrophy such as
tamsulosin) at time of enrollment (Appendix 21.4)
- Prostate volume (by US, CT or MRI measurement) < 50 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
- Age ≥ 18 years
- Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 (Appendix 21.5).
- 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
- Psychiatric illness/social situations that would limit compliance with study
- Prior pelvic radiation therapy
- Prior prostatectomy
- Inflammatory bowel disease or connective tissue disease requiring medical management