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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
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
September 1, 2022
Last Updated
August 11, 2023
Sponsor
University of Rochester
Collaborators
Medical College of Wisconsin
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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
No
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
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.
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
No
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
Email
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
Email
christine_huggins@urmc.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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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