Telmisartan in Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug & Other
  • EARLY_PHASE1
  • Tyler J Curiel
  • 18 Years -


Study Purpose

The goal of this clinical trial is to learn about the tolerability of telmisartan in patients with prostate cancer.

Intervention

Drug : Telmisartan

Other : Standard of Care Regimen


Eligibility Requirements

info icon Participants must be ≥18 years of age.

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

info icon 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

info icon Participants must be receiving or likely to receive one of the following SOC agents for PC:

info icon cabazitaxel, docetaxel (alone or plus abiraterone) olaparib, rucaparib, or talazoparib plus enzalutamide

info icon Participants must have

info icon ECOG performance status of 0-2

info icon Adequate hepatic (SCOT ≤3x ULN) and renal function (serum creatinine ≤2.5 or estimated GFR \>30 cc/min)

info icon Standing systolic blood pressure \>/= 110mm Hg

info icon If not on active surveillance, patient mut have castrate level testosterone

info icon No contraindication to telmisartan, including ACE inhibitor use in the 6 weeks prior to projected telmisartan start on trial

info icon All participants must have a systolic blood pressure \>110 mm Hg during study enrollment assessment and throughout the study

info icon If participants are concurrently treated for hypertension, they must be able to allow telmisartan in addition to, or replacing their antihypertensive regimen

info icon Participants must be able to withstand planned research phlebotomies (Hb \>10 gm/dl).

info icon Participants must have a blood prostate specific antigen \> 1 ng/ml at study entry using the Roche Cobas immunoassay.

info icon 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.

info icon Participants who fall into one of the following categories will NOT be eligible for this study:

info icon Angiotensin l receptor blocker use currently or within the 30 days prior to day 1, cycle 1.

info icon Patients with hypertensive urgency or emergency as defined in N Engl J Med. 2019 Nov 7;381(19):1843-1852. doi:10.1056/NEJMep1901117

info icon Patients who are incarcerated or homeless

info icon 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.

info icon Patients on lithium therapy in any form

info icon Patients who received rituximab or amifostine within 30 days prior to first telmisartan dose on this study

info icon Patients on ramapril

info icon Patients on digoxin who do not consent to monthly digoxin blood level testing

Recruiting status

Recruiting

Estimated enrollment

36

 
Study start date

Apr 22, 2024

Study end date

Apr 01, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug & Other

Study phase

EARLY_PHASE1

Allocation

Non Randomized

 

Sponsor:

Tyler J Curiel

Collaborator:

N/A

Investigator:

Rodwell Mabaera, MD

NCT06168487

Clinic Location Investigator Distance RECRUITING STATUS Contact