Telmisartan for Prostate Cancer

This study is looking at telmisartan, a medication, for men with prostate cancer. You might receive telmisartan alone or together with your usual prostate cancer treatment. The main goal is to see how well patients tolerate telmisartan over 12 months, meaning if it causes side effects or affects blood pressure too much. Researchers will also gather information on how effective telmisartan might be. To join, you must be at least 18 years old and your current prostate cancer treatment shouldn't need immediate changes. The study plans to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for tolerability is measured at 12 months.

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NCT06168487

Telmisartan in Prostate Cancer

Recruiting
PHASE1Ages 18+Interventional
Tyler J Curiel
~36 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:TelmisartanStandard of Care Regimen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tolerability of oral telmisartan
Measured over 12 months
Prostate Cancer
1 sites across 1 states
New Hampshire1
  • Rodwell Mabaera, MD · PRINCIPAL_INVESTIGATOR · Dartmouth Health

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Eligibility criteria

Inclusion

Participants must be ≥18 years of age.
Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
Participants must not require immediate change in SOC treatment, i.e., patients with stable PSA (do not meet PCWG310 criteria for PSA progression), or with rising PSA but they remain on SOC treatment (defined as having met PCWG3 criteria for PSA progression, but do not have clinical/radiographic progression and have not met criteria for an immediate change in therapy based on PSA doubling time) as determined by their primary oncologist
Participants must be receiving or likely to receive one of the following SOC agents for PC:
Participants must have
ECOG performance status of 0-2
Adequate hepatic (SCOT ≤3x ULN) and renal function (serum creatinine ≤2.5 or estimated GFR \>30 cc/min)
Standing systolic blood pressure \>/= 110mm Hg
If not on active surveillance, patient mut have castrate level testosterone
No contraindication to telmisartan, including ACE inhibitor use in the 6 weeks prior to projected telmisartan start on trial
All participants must have a systolic blood pressure \>110 mm Hg during study enrollment assessment and throughout the study
If participants are concurrently treated for hypertension, they must be able to allow telmisartan in addition to, or replacing their antihypertensive regimen
Participants must be able to withstand planned research phlebotomies (Hb \>10 gm/dl).
Participants must have a blood prostate specific antigen \> 1 ng/ml at study entry using the Roche Cobas immunoassay.
Participants must be able to take or have taken their own blood pressure per the study protocol (daily during telmisartan escalation and for two weeks after the final escalation and weekly thereafter for the following month and then monthly) if normotensive at enrollment.

Exclusion

Angiotensin l receptor blocker use currently or within the 30 days prior to day 1, cycle 1.
Patients with hypertensive urgency or emergency as defined in N Engl J Med. 2019 Nov 7;381(19):1843-1852. doi:10.1056/NEJMep1901117
Patients who are incarcerated or homeless
Patients who are receiving PC-specific treatment aside from cabazitaxel, docetaxel, olaparib, rucaparib, abiraterone or talazoparib plus enzalutamide or have plans to undergo the same during the study period, except local irradiation therapy to PC lesions.
Patients on lithium therapy in any form
Patients who received rituximab or amifostine within 30 days prior to first telmisartan dose on this study
Patients on ramapril
Patients on digoxin who do not consent to monthly digoxin blood level testing
  • Tolerability of oral telmisartan12 months

    Ability of the participant to tolerate telmisartan alone or with standard of care agents as defined by maintaining a systolic blood pressure \>110mmHG and are without greater than grade 2 toxicities