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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05530655
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lisinopril Tablets — DRUG
    This is a dose escalation study of 5 mg, 10 mg and 20 mg doses given once a day.

Study Details

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.

Key Dates

Start date
Feb 20, 2024
Status verified
Jun 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control group
    Patients who receive radiation but no intervention
  • Experimental: Intervention group

Primary Outcome Measure

Mean change in Expanded Prostate Index Composite score [ Time Frame: baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmot Cancer InstituteRochesterNew York14642
Therese Smudzin
[email protected]
585-275-7848

Find similar trials in Rochester, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Wilmot Cancer Institute· Rochester, NY

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