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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.