Prostate CancerEarly Phase 1NCT05530655
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
A Early Phase 1 study testing Lisinopril Tablets in people with Prostate Cancer and Radiation Toxicity, run by University of Rochester at 1 site in United States.
Trial summary
This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Radiation Toxicity, Urinary Complication
- What is being tested?
- Lisinopril Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 1 Jan 2028
- Phase
- Early Phase 1
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.
- Be stage M0 based on the standard of care staging imaging
- Be able to read English
- Have the psychological ability and general health that permits completion of the study requirements and required follow up
- Be ≥18 and < 70 years of age
- Have ECOG performance status of 0 to 2 within 180 days prior to enrollment
Show all 11Show fewer
- Have adequate renal function with creatinine clearance > 30 mL/min within 30 days prior to registration
- Have hematologic and hepatic function deemed adequate for planned treatment by the treating investigator within 90 days prior to registration, including:
- hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors
- platelet count ≥100,000/µL independent of transfusion and/or growth factors
- Have a baseline systolic blood pressure of >130.
Who cannot join
- Have received prior pelvic radiotherapy
- Be taking lisinopril or other RAS modifying drug within two months prior to registration
- Have had a prior allergic reaction to lisinopril
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
Wilmot Cancer Institute
Rochester, New York, 14642
Therese Smudzin, 585-275-7848, Therese_Smudzin@urmc.rochester.edu
About this study
Official title: A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.
- Conditions
- Prostate Cancer, Radiation Toxicity, Urinary Complication
- Being tested
- Lisinopril Tablets
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisinopril TabletsDrug
This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients who receive radiation but no intervention |
| Intervention group | Experimental | Not described Receives: Drug: Lisinopril Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Expanded Prostate Index Composite score
Patient reported outcomes capturing urinary symptoms will be collected using the Expanded Prostate Index Composite (EPIC) patient reported outcome questionnaire prior to radiation on the first day of treatment, weekly during radiation, and approximately 1 month, 3 months, 6 months, and 12 months after radiation. The EPIC bladder domain score will quantify patient reported urinary symptoms. The EPIC bladder domain consists of 12 items each scored on a Likert scale with an overall score transformed to a 0-100 scale. A higher score indicates worse outcome.
Measured: baseline to 12 months
change in the percentage of patients with positive blood test in urine
Measured: baseline to 12 months
percentage of participants who achieve a dose of 20 mg
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start20 Feb 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 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 University of RochesterThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Principal investigator, Hong Zhang, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530655
- Sponsor's protocol ID
- STUDY00007510_URGUP23077
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Preferred Dose of the Angiotensin Converting Enzyme Inhibitor Lisinopril for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT05530655
- Acronym / sponsor ID
- STUDY00007510_URGUP23077
- Conditions
- Prostate Cancer, Radiation Toxicity, Urinary Complication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Sep 2022 (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.
This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients who receive radiation but no intervention |
| Intervention group | Experimental | Drug: Lisinopril Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.
- Be stage M0 based on the standard of care staging imaging
- Be able to read English
- Have the psychological ability and general health that permits completion of the study requirements and required follow up
- Be ≥18 and < 70 years of age
Key exclusion criteria (3 listed)
- Have received prior pelvic radiotherapy
- Be taking lisinopril or other RAS modifying drug within two months prior to registration
- Have had a prior allergic reaction to lisinopril
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 |
|---|---|---|
| Lisinopril TabletsThis is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day. | Drug | Intervention group |
Primary outcome
Mean change in Expanded Prostate Index Composite score
Time frame: baseline to 12 months
Patient reported outcomes capturing urinary symptoms will be collected using the Expanded Prostate Index Composite (EPIC) patient reported outcome questionnaire prior to radiation on the first day of treatment, weekly during radiation, and approximately 1 month, 3 months, 6 months, and 12 months after radiation. The EPIC bladder domain score will quantify patient reported urinary symptoms. The EPIC bladder domain consists of 12 items each scored on a Likert scale with an overall score transformed to a 0-100 scale. A higher score indicates worse outcome.
change in the percentage of patients with positive blood test in urine
Time frame: baseline to 12 months
percentage of participants who achieve a dose of 20 mg
Time frame: 12 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 23 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lisinopril Tablets in people with Prostate Cancer and Radiation Toxicity, run by University of Rochester 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 11 inclusion and 3 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 23 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Therese Smudzin (585-275-7848, Therese_Smudzin@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Expanded Prostate Index Composite score (time frame: baseline to 12 months). The study lists 3 primary outcomes in all. 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 23 Jul 2026.