Phase
Condition
Prostate Cancer
Urologic Cancer
Prostate Disorders
Treatment
Standard of Care Regimen
Telmisartan
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥18 years of age.
Participants must be able and willing to provide informed consent or have asurrogate capable of providing same.
Participants must not require immediate change in SOC treatment, i.e., patients withstable PSA (do not meet PCWG310 criteria for PSA progression), or with rising PSAbut they remain on SOC treatment (defined as having met PCWG3 criteria for PSAprogression, but do not have clinical/radiographic progression and have not metcriteria for an immediate change in therapy based on PSA doubling time) asdetermined by their primary oncologist
Participants must be receiving or likely to receive one of the following SOC agentsfor 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 orestimated 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 priorto projected telmisartan start on trial
All participants must have a systolic blood pressure >110 mm Hg during studyenrollment assessment and throughout the study
If participants are concurrently treated for hypertension, they must be able toallow 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 entryusing the Roche Cobas immunoassay.
Participants must be able to take or have taken their own blood pressure per thestudy protocol (daily during telmisartan escalation and for two weeks after thefinal escalation and weekly thereafter for the following month and then monthly) ifnormotensive at enrollment.
Exclusion
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 toundergo the same during the study period, except local irradiation therapy to PClesions.
Patients on lithium therapy in any form
Patients who received rituximab or amifostine within 30 days prior to firsttelmisartan dose on this study
Patients on ramapril
Patients on digoxin who do not consent to monthly digoxin blood level testing
Study Design
Study Description
Connect with a study center
Dartmouth Health
Lebanon, New Hampshire 03756
United StatesActive - Recruiting

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