- 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
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.
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
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
Publications
SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; 2023 Apr 19. Available from: https://seer.cancer.gov/statistics-network/explorer/. Data source(s): SEER Incidence Data, November 2022 Submission (1975-2020), SEER 22 registries. updated: 2023 Jun 8. Accessed Oct 5, 2023
Murray C, Bai H, Ontiveros CO, et al. Pharmacologic tumor PDL1 depletion as a novel approach to overcome treatment resistance. The Journal of Immunology. 2023;210(1_Supplement):230.08-230.08. doi:10.4049/jimmunol.210.Supp.230.08
Uemura H, Miyoshi Y, Ishiguro H, Nakaigawa N, Noguchi K, Kubota Y. Effectiveness of angionten II receptor blocker (ARB), candesartan, in the treatment of hormone refractory prostate cancer (HRPC). presented at: 2004 ASCO Annual Meeting; 2004
Websites
N/A
NCT06168487
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