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Lisinopril for Preventing Urinary Side Effects in Prostate Cancer Radiotherapy
Phase < 1
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will help determine the best dose of lisinopril for men with prostate cancer undergoing radiation, and whether the drug can help relieve urinary symptoms.
Who is the study for?
Men under 70 with non-metastatic prostate cancer who are set for radiation therapy at Wilmot Cancer Institute can join. They must be in good health, able to follow the study plan, have normal kidney and liver function, not have had pelvic radiotherapy before, and not be on lisinopril or similar drugs recently.
What is being tested?
The trial is testing different doses of Lisinopril tablets to find the best one for preventing urinary problems after radiation treatment for prostate cancer. It will also look at how Lisinopril affects certain biomarkers related to these urinary symptoms.
What are the potential side effects?
Lisinopril may cause side effects like coughing, dizziness due to low blood pressure, headaches, fatigue, nausea or problems with kidney function. Some people might experience allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in Expanded Prostate Index Composite score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention
Patients who receive radiation but no intervention
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Who is running the clinical trial?
Medical College of WisconsinOTHER
628 Previous Clinical Trials
1,179,846 Total Patients Enrolled
University of RochesterLead Sponsor
866 Previous Clinical Trials
545,350 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
175 Patients Enrolled for Urinary Tract Infection
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been mostly active and able to care for myself in the past 6 months.My cancer has not spread to distant parts of my body.I have had radiation therapy to my pelvic area before.I am mentally and physically able to follow the study's requirements.I have prostate cancer and am eligible for radiation therapy aimed at curing it.I am between 18 and 70 years old.My kidneys are working well, with a creatinine clearance over 30 mL/min.My blood and liver tests meet the required levels for treatment.I have been taking lisinopril or a similar drug in the last two months.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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