30 Participants Needed

Lisinopril for Preventing Urinary Side Effects in Prostate Cancer Radiotherapy

CH
TS
Overseen ByTherese Smudzin
Age: 18+
Sex: Male
Trial Phase: Phase < 1
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of lisinopril for men with non-metastatic prostate cancer undergoing radiation treatment to manage urinary side effects. Although typically used to treat high blood pressure, researchers are investigating whether lisinopril can also alleviate urinary problems caused by radiation. Participants will receive either radiation alone or radiation with lisinopril to compare outcomes. Men with prostate cancer who are receiving radiation treatment and have not recently taken lisinopril or similar medications might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding lisinopril's effects in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking lisinopril or similar drugs within two months before joining the study.

Is there any evidence suggesting that lisinopril is likely to be safe for humans?

Research has shown that lisinopril, a medication commonly used to treat high blood pressure, is under study for its potential to alleviate urinary side effects in men undergoing radiation therapy for prostate cancer. The FDA has already approved lisinopril for other uses, confirming its well-known safety profile. Most people tolerate it well, though it can cause side effects like any medication. Common side effects may include dizziness or a cough, while serious side effects are rare. As this study is in the early stages, researchers are still determining the best dose and are carefully monitoring for any side effects. If lisinopril proves safe and effective, it could help reduce urinary problems caused by radiation therapy.12345

Why do researchers think this study treatment might be promising?

Most treatments for urinary side effects from prostate cancer radiotherapy focus on managing symptoms after they occur. But Lisinopril, a blood pressure medication, is being explored for its potential to prevent these side effects altogether. Researchers are excited because Lisinopril works by protecting blood vessels and tissues from radiation damage, which could mean fewer urinary issues for patients during and after their cancer treatment. This prevention-focused approach is quite different from current options that only address symptoms after they've developed.

What evidence suggests that lisinopril might be an effective treatment for urinary side effects in prostate cancer radiotherapy?

Research has shown that lisinopril, which participants in this trial may receive, might help prevent urinary problems in men undergoing radiation treatment for prostate cancer. This medication, commonly used to lower high blood pressure, could improve blood flow to the urinary system. Improved blood flow might reduce urinary symptoms after radiation. Additionally, studies on similar drugs have demonstrated a decrease in some radiation-related side effects. While more research is needed, these early findings suggest that lisinopril could help manage urinary issues in this context.13567

Are You a Good Fit for This Trial?

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.

Inclusion 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 am mentally and physically able to follow the study's requirements.
See 5 more

Exclusion Criteria

Have had a prior allergic reaction to lisinopril
I have had radiation therapy to my pelvic area before.
I have been taking lisinopril or a similar drug in the last two months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation treatment for prostate cancer

6-8 weeks
Weekly visits during radiation

Treatment

Participants receive lisinopril to determine the preferred dose for preventing urinary toxicity

Concurrent with radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 1 month, 3 months, 6 months, and 12 months post-radiation

What Are the Treatments Tested in This Trial?

Interventions

  • Lisinopril
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Medical College of Wisconsin

Collaborator

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

In a study of 115 patients at the University of Wisconsin and 186 patients at the University of Hawaii, those taking angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) showed a significantly higher rate of pathologic complete response (pCR) to neoadjuvant radiation therapy for rectal cancer, with a 3-fold increase in the UW cohort and a 2-fold increase in the UH cohort.
Multivariate analyses indicated that ACEI/ARB use is a strong predictor of pCR, with an odds ratio of 4.02, suggesting these medications may enhance the effectiveness of neoadjuvant radiation therapy in rectal cancer patients.
Increased tumor response to neoadjuvant therapy among rectal cancer patients taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.Morris, ZS., Saha, S., Magnuson, WJ., et al.[2022]
In a study using PC-3 human prostate cancer cells and an animal model, combining radiotherapy (RT) with naftopidil significantly delayed tumor growth more effectively than either treatment alone.
The combination therapy also suppressed the upregulation of the antioxidant enzyme manganese superoxide dismutase (MnSOD), which is often increased in response to RT, suggesting that naftopidil may enhance the effectiveness of RT by targeting protective mechanisms in cancer cells.
Combination treatment with naftopidil increases the efficacy of radiotherapy in PC-3 human prostate cancer cells.Iwamoto, Y., Ishii, K., Kanda, H., et al.[2018]
In a study of 108 patients undergoing radical external beam radiotherapy for localized prostate cancer, the use of the α-blocker tamsulosin significantly reduced the incidence of acute urinary retention (AUR) compared to a control group, indicating its efficacy in managing radiotherapy-induced urinary symptoms.
While tamsulosin improved patient-reported symptoms, the study found no independent predictive factors to identify which patients would benefit most from the treatment, suggesting that its use should be considered selectively.
A-blockers for the management of lower urinary tract symptoms in patients with prostate cancer treated with external beam radiotherapy: a randomized controlled study.Tsirkas, K., Zygogianni, A., Kougioumtzopoulou, A., et al.[2021]

Citations

NCT05530655 | A Study to Determine the Preferred Dose ...This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also ...
Lisinopril for the Prevention of Urinary Side Effects ...This may improve blood flow to the urinary system, which may help prevent urinary side effects following radiation therapy for prostate adenocarcinoma.
A Study to Determine the Preferred Dose of the Drug ...This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment.
The Effect of the Concurrent Use of Angiotensin-Converting ...Conclusions: ACEI use is associated with a reduction in radiation pneumonitis, but evidence for other radiotherapy-related toxicity and survival ...
Dosimetry, clinical factors and medication intake ...To identify dosimetry, clinical factors and medication intake impacting urinary symptoms after prostate radiotherapy. Material and methods. Data describing ...
Lisinopril for Preventing Urinary Side Effects in Prostate ...This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment.
Modeling Normal Bladder Injury After Radiation Therapy - PMCSymptoms of radiotherapy-induced bladder injury for prostate cancer patients include increased urinary frequency, urinary retention, dysuria, and hematuria ...
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