Ultra-hypofractionated Radiation in Prostate Cancer

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.

Eligibility Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

Principal Investigator

Xinglei Shen, MD

Study Contact

Leah K Miller, lmiller25@kumc.edu, 913-588-3670, Michelle Faucheux, 913-588-9927 mfaucheux@kumc.edu

Estimated Completion Date

Monday, March 1, 2021

ClinicalTrials.gov #

NCT03486821
04/02/2018