Prostate CancerNCT06817668
Evaluating Tolerability of ePUHRT With Brachytherapy Boost
A study testing ePURT 5Gy x 5 fractions with single HDR boost of 15Gy in people with Prostate Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years old at the time of informed consent
- Capable of providing informed consent and HIPAA authorization
- Karnofsky performance score ≥ 70
- Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
- Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
Who cannot join
- Prior pelvic irradiation treatment
- Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
- Evidence of nodal or distant disease on screening diagnostic work up.
- Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
- International Prostate Symptom Score (IPSS) score > 16 despite medical therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Kathy Lauer, 317-962-3172, klauer@iuhealth.org
About this study
Official title: Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Read the detailed description
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
- Conditions
- Prostate Cancer
- Being tested
- ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
- Keywords
- Brachytherapy boost
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePURT 5Gy x 5 fractions with single HDR boost of 15GyRadiation
ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
| Study group | Role | What they receive |
|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15Gy | Experimental | Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy. Receives: Radiation: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with acute grade ≥ 2 GU toxicity
Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.
Measured: 3 months
Secondary outcomes (2)
Percentage of participants with acute grade ≥ 2 GI toxicity
Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5
Measured: 3 months
Percentage of participants with acute grade ≥ 2 GU toxicity
Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start5 Mar 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ishaq, Indiana University
- Investigators
- Omar Ishaq, MD, Principal investigator, Indiana University Simon Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817668
- Sponsor's protocol ID
- CTO-IUSCCC-0832
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06817668
- Acronym / sponsor ID
- CTO-IUSCCC-0832
- Conditions
- Prostate Cancer
- Keywords
- Brachytherapy boost
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Feb 2025 (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 purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Detailed description
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15Gy | Experimental | Radiation: ePURT 5Gy x 5 fractions with single HDR boost of 15GySingle arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old at the time of informed consent
- Capable of providing informed consent and HIPAA authorization
- Karnofsky performance score ≥ 70
- Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
- Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
Key exclusion criteria (5 listed)
- Prior pelvic irradiation treatment
- Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
- Evidence of nodal or distant disease on screening diagnostic work up.
- Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
- International Prostate Symptom Score (IPSS) score > 16 despite medical therapy
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 |
|---|---|---|
| ePURT 5Gy x 5 fractions with single HDR boost of 15GyePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy. | Radiation | ePURT 5Gy x 5 fractions with single HDR boost of 15Gy |
Primary outcome
Percentage of participants with acute grade ≥ 2 GU toxicity
Time frame: 3 months
Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.
2 secondary outcomes
Percentage of participants with acute grade ≥ 2 GI toxicity
Time frame: 3 months
Percentage of participants with acute grade ≥ 2 GU toxicity
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Omar Ishaq, MD principal investigator
Indiana University Simon Comprehensive Cancer 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 ePURT 5Gy x 5 fractions with single HDR boost of 15Gy in people with Prostate Cancer, run by Indiana University 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 5 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: looking for participants now, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Ishaq, MD (317-944-2524, oishaq@iuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with acute grade ≥ 2 GU toxicity (time frame: 3 months). 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 26 Sep 2025.