Ultra-hypofractionated Radiation in Prostate Cancer (NCT03486821) | Clinical Trial Compass
CompletedNot Applicable
Ultra-hypofractionated Radiation in Prostate Cancer
United States13 participantsStarted 2018-03-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Ability of participant to sign a written informed consent.
* Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA \< 20
* IPSS score \< 15 (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