Early Stage Prostate CancerNCT03486821
Ultra-hypofractionated Radiation in Prostate Cancer
A study testing Hypofractionated Radiation in people with Early Stage Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Early Stage Prostate Cancer
- What is being tested?
- Hypofractionated Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, 66190
About this study
Official title: Pilot Trial of Ultra-hypofractionated Radiation in Early 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.
Read the detailed description
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.
- Conditions
- Early Stage Prostate Cancer
- Being tested
- Hypofractionated Radiation
- Keywords
- Radiation Therapy, ultra-short Radiation, SBRT, prostate, quality of life, financial toxicity
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiationRadiation
All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Hypofrac Radiation Therapy | Experimental | 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. Receives: Radiation: Hypofractionated Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Rates
Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients
Measured: up to 5 year post radiation
Secondary outcomes (5)
Biochemical Control Rate
Biochemical freedom from progression as defined by ASTRO Phoenix criteria at 3 years
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 months, 6 months, and 12 month visits only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start22 Mar 2018
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinglei Shen, University of Kansas Medical Center
- Investigators
- Xinglei Shen, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486821
- Sponsor's protocol ID
- IIT-2017-PROS-UltraHypoFracRT
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer
- ClinicalTrials.gov ID
- NCT03486821
- Acronym / sponsor ID
- IIT-2017-PROS-UltraHypoFracRT
- Conditions
- Early Stage Prostate Cancer
- Keywords
- Radiation Therapy, ultra-short Radiation, SBRT, prostate, quality of life, financial toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofrac Radiation Therapy | Experimental | Radiation: Hypofractionated RadiationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated RadiationAll patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy. | Radiation | Hypofrac Radiation Therapy |
Primary outcome
Toxicity Rates
Time frame: up to 5 year post radiation
Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients
5 secondary outcomes
Biochemical Control Rate
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
Time frame: 3 year
RTOG Acute Toxicity Rate
Time frame: 90 days
Oxidative stress as a predictor of toxicity
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
Time frame: 3 months, 6 months, and 12 month visits only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinglei Shen, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation in people with Early Stage Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity Rates (time frame: up to 5 year post radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.