An interventional study of Hypofractionated Radiation in Early Stage Prostate Cancer, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 59 studies in Financial Stress with a site in United States — 19 open to participants now, 26 under way, none of them phase 3. Financial Stress · United States.
Among the 59 studies in Financial Stress with a site in United States, this one is the 49th largest by enrollment of the 51 interventional ones that give a count, is one of 3 that started in 2018, is one of 51 with no phase, and was the 5th registered.
100 studies on the registry are indexed under Financial Stress; 34 are open to participants now.
Browse Financial Stress studies →19 of the 59 studies in Financial Stress with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 18+
University of Utah · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18–35
Washington University School of Medicine · Sites in United States
Ages 18+
Cedars-Sinai Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 24 Financial Stress studies recruiting now, 17 (71%) set no upper age limit and 6 (25%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2018.
This study's enrollment of 13 is below the median of 96 across 61 interventional studies indexed under Financial Stress.
Median enrollment 70 across the 51 interventional studies, 346 across the 8 observational. Of the 31 that completed or were terminated, 4 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 59 have an industry lead sponsor. The 10 most frequent:
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
University of Kansas Medical Center has 1 study filed under Financial Stress — fewer than ten, so there is no comparison to draw.
7 of the studies in Financial Stress with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06348160University Hospitals Cleveland Medical CenteriHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes | 2026-11-22 |
| NCT07217262Cedars-Sinai Medical CenterProactive Costs of Care Study | 2027-04 |
| NCT07724041University of Alabama at BirminghamFeasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress | 2027-05 |
| NCT06849752The Cleveland ClinicEarly Assessment and Initiation of GuideLine-Directed Evidence-Based Management-HF | 2027-06 |
| NCT06283251Dana-Farber Cancer InstitutePediRISE Feasibility | 2027-06-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 59 studies in Financial Stress with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative to standard of care. Data does not yet exist for the safety and efficacy of this regimen.
However, the feasibility of ultra-short radiation therapy treatments has already been demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR brachytherapy has been adopted at high volume cancers centers as a standard treatment for prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to other treatment modalities.
Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses, but target volume coverage and urethral dose was not significantly different. These data suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible, efficacious and tolerable.
Eligible patients include all patients who are otherwise eligible for standard 5 fraction SBRT prostate. Study population will be low and intermediate patients with good urinary function (as defined by small prostate volume and low IPSS score). SBRT treatment will be delivered to the prostate to 12.5 Gy x 2 fractions.
Hormonal therapy is permitted on this study. Permitted agents include: leuprolide (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon).
Rectal sparing with hydrogel spacer (SpaceOAR) will be encouraged.
All patients will be enrolled with interim safety analyses after every occurrence of a grade 3 acute or late toxicity. Interval safety analysis will also be performed for recurrence and decrease in EPIC GU domain quality of life. Biospecimen and financial toxicity data will also be collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE: Acceptable forms of are listed below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy. Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan. Each treatment should take about 10-20 minutes.
Radiation: Hypofractionated Radiation
All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.
Toxicity Rates
Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients
Time frame: up to 5 year post radiation
Biochemical Control Rate
Biochemical freedom from progression as defined by ASTRO Phoenix criteria at 3 years
Time frame: 1 month post-Radiation Therapy (RT), every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
Radiation Therapy Oncology Group (RTOG) Late Toxicity Rate
Rate of Grade 3+ gastrointestinal (GI) or genitourinary (GU) late toxicity at 3 years as defined by RTOG late toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.
Time frame: 3 year
RTOG Acute Toxicity Rate
Rate of Grade 2+ GI or GU acute toxicity within 90 days of treatment as defined by RTOG acute toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.
Time frame: 90 days
Oxidative stress as a predictor of toxicity
exploring the oxidative stress markers of the patient to use as a predictor of acute and late toxicty
Time frame: 1 month post-RT, every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
Financial Toxicity Measurement
Determined by evaluation of patient completion of questionnaire
Time frame: 3 months, 6 months, and 12 month visits only
Ran from Mar 2018 to primary completion in Mar 2026, 95 months.
Of 51 non-industry interventional studies with no phase under Financial Stress, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 95 months is above that.
Counting every sponsor, half of 51 studies reached it within 20 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Kansas Medical Center →