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A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

Primary Purpose

Prostate Cancer, Radiation Toxicity, Urinary Complication

Status

Not yet recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lisinopril Tablets

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Exclusion Criteria:

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

Sites / Locations

Wilmot Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

Patients who receive radiation but no intervention

Outcomes

Primary Outcome Measures

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.

change in the percentage of patients with positive blood test in urine

percentage of participants who achieve a dose of 20 mg

Secondary Outcome Measures

Full Information

NCT ID

NCT05530655

First Posted

September 1, 2022

Last Updated

August 11, 2023

Sponsor

University of Rochester

Collaborators

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT05530655

Brief Title

A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Radiation Toxicity, Urinary Complication

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Patients who receive radiation but no intervention

Arm Title

Intervention group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lisinopril Tablets

Intervention Description

This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.

Primary Outcome Measure Information:

Title

Mean change in Expanded Prostate Index Composite score

Description

Time Frame

baseline to 12 months

Title

change in the percentage of patients with positive blood test in urine

Time Frame

baseline to 12 months

Title

percentage of participants who achieve a dose of 20 mg

Time Frame

12 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Huggins, PhD

Phone

585-275-5973

Christine_huggins@urmc.rochester.edu

Facility Information:

Facility Name

Wilmot Cancer Institute

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Huggins, PhD

christine_huggins@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

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