Telmisartan in Prostate Cancer

Launched by TYLER J CURIEL · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called telmisartan to understand how well it can be tolerated by men with prostate cancer. The main goal is to see if telmisartan can be safely used alongside other standard treatments for prostate cancer without causing serious side effects. If you are a man aged 18 or older with prostate cancer and are currently stable on your treatment, you may be eligible to participate in this trial.

Participants will need to have certain health conditions, like having a specific level of prostate-specific antigen (PSA) in their blood and a blood pressure above a certain level. Throughout the study, participants will be asked to monitor their blood pressure regularly. If you are interested in joining this trial, it's important to know that you cannot be on certain other medications that affect blood pressure or be receiving specific prostate cancer treatments outside of the ones listed. The trial is currently recruiting participants, and taking part could help researchers learn more about potential new treatment options for prostate cancer.

Gender

MALE

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 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