RECRUITING

Telmisartan in Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn about the tolerability of telmisartan in patients with prostate cancer, but evidence for treatment efficacy will also be gathered.

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2027-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06168487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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

Inclusion Criteria

Exclusion 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:
* 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.

* 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

Contacts and Locations

Study Contact

Kayla Fay

CONTACT

603-650-5000

kayla.a.fay@hitchcock.org

Principal Investigator

Rodwell Mabaera, MD

PRINCIPAL_INVESTIGATOR

Dartmouth Health

Study Locations (Sites)

Dartmouth Health

Lebanon, New Hampshire, 03756

United States

Collaborators and Investigators

Sponsor: Tyler J Curiel

Rodwell Mabaera, MD, PRINCIPAL_INVESTIGATOR, Dartmouth Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer