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Angiotensin II Receptor Blocker

Telmisartan for Prostate Cancer

Phase < 1

Recruiting

Led By Rodwell Mabaera, MD

Research Sponsored by Tyler J Curiel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.

Participants must be ≥18 years of age.

Must not have

Inadequately treated or uncontrolled hypertension.

Patients on ramapril.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well telmisartan works in treating prostate cancer in men.

Who is the study for?

Men over 18 with prostate cancer and a PSA level >1 ng/ml can join this trial. They must be stable on or likely to start standard treatments, able to monitor their blood pressure, consent themselves (or have someone who can), not need immediate treatment changes, and have normal or controlled high blood pressure that allows for telmisartan use.

What is being tested?

This study is testing the safety of adding telmisartan to the usual prostate cancer treatments. Participants will either receive telmisartan alongside their standard care regimen or continue with just the standard care to see how well they tolerate the addition of telmisartan.

What are the potential side effects?

Telmisartan may cause dizziness due to low blood pressure, fatigue, nausea, and an increased risk of high potassium levels. It might also affect kidney function and could interact with other medications used for controlling blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can give my consent or have someone who can consent for me.

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I am 18 years old or older.

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My PSA level is over 1 ng/ml.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not well-controlled.

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I am currently taking ramipril.

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I am willing and able to add standard treatment to telmisartan if needed.

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I am currently taking lithium.

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I am not willing to have monthly blood tests for my digoxin treatment.

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I am unable to understand and give consent for my own treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tolerability of oral telmisartan

Secondary study objectives

Increase in tumor DNA damage

Other study objectives

Reduction of blood prostate specific antigen

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

Group I: Cohort 2: Telmisartan + Standard of Care RegimenExperimental Treatment2 Interventions

Patients will receive telmisartan with cabazitaxel or docetaxel without abiraterone), or telmisartan with docetaxal with abirateron or olaparib or rucaparib, or talazoparib plus enzalutamide.

Group II: Cohort 1: Telmisartan AloneExperimental Treatment1 Intervention

Patients will receive telmisartan alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telmisartan

1999

Completed Phase 4

~14550

0 / 9Eligibility criteria met