No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
36 (estimated)
Sponsor
Tyler J Curiel · Other
Who this trial is looking for
This trial is looking for men with prostate cancer to test a medication called telmisartan. Participants will need to meet certain health requirements and consent to monitoring during the study.
Are You a Good Fit for This Trial?
Must be takingCabazitaxelDocetaxelOlaparibRucaparibAbirateroneTalazoparib
You may be able to join if
I am at least 18 years old.
I can provide informed consent or have someone who can.
I have prostate cancer and my PSA levels are stable or monitored.
I am receiving standard treatment for prostate cancer.
I have a good performance status and can tolerate the study procedures.
I have certain blood pressure levels.
I have a prostate-specific antigen level over 1 ng/ml.
I can monitor my blood pressure as required by the study.
You may not be able to join if
I have been using certain blood pressure medications recently.
I have a serious hypertension condition.
I am currently homeless or incarcerated.
I am receiving other prostate cancer treatments not allowed in the trial.
I have taken certain medications like rituximab recently.
I am on lithium therapy.
I take digoxin and do not consent to testing my blood levels for it.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn about the tolerability of telmisartan in patients with prostate cancer, but evidence for treatment efficacy will also be gathered.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 crit…
Inclusion Criteria:
* 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:
cabazitaxel, docetaxel (alone or plus abiraterone) olaparib, rucaparib, or talazoparib plus enzalutamide
* 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 Criteria:
Participants who fall into one of the following categories will NOT be eligible for this study:
* 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
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