Phase I Non-Randomized, Unblinded, Single-Center Trial of Oral Telmisartan Alone or Combined With Selected Standard of Care Therapies for Prostate Cancer

STUDY02002057

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

2024-06-01

2026-04-01

2027-04-01

Not yet recruiting

Early phase I

42

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 who are not receiving one of the above agents 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) * 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: * Adults who are unable to provide informed consent. * Angiotensin l receptor blocker use currently or within the 30 days prior to day 1, cycle 1. * Patients unwilling or unable to have SOC PC agent(s) added to telmisartan if telmisartan is started per protocol before SOC PC treatment is administered. * Inadequately treated or uncontrolled hypertension. * Patients who are incarcerated, homeless, or have active substance drug/alcohol dependence or abuse history. * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-05-16