Telmisartan in Prostate Cancer

NCT06168487 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: STUDY02002057NCI-2024-07041
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Tolerability of oral telmisartan

  Ability of the participant to tolerate telmisartan alone or with standard of care agents as defined by maintaining a systolic blood pressure \>110mmHG and are without greater than grade 2 toxicities

  12 months

Secondary Outcomes (1)

• Increase in tumor DNA damage

  24 months

Other Outcomes (1)

• Reduction of blood prostate specific antigen

  24 months

Study Arms (2)

Cohort 1: Telmisartan Alone

EXPERIMENTAL

Patients will receive telmisartan alone.

Drug: Telmisartan

Cohort 2: Telmisartan + Standard of Care Regimen

EXPERIMENTAL

Patients will receive telmisartan with cabazitaxel or docetaxel without abiraterone), or telmisartan with docetaxal with abirateron or olaparib or rucaparib, or talazoparib plus enzalutamide.

Drug: Telmisartan; Other: Standard of Care Regimen

Interventions

Telmisartan DRUG

Patients will be given telmisartan alone or with standard of care chemotherapy.

Also known as: Micardis

Cohort 1: Telmisartan Alone; Cohort 2: Telmisartan + Standard of Care Regimen

Standard of Care Regimen OTHER

Standard of Care Regimen

Cohort 2: Telmisartan + Standard of Care Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tyler J Curiel: lead

Study Sites (1)

Dartmouth Health

Lebanon, New Hampshire, 03756, United States

RECRUITING

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rodwell Mabaera, MD

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla Fay

CONTACT

603-650-5000; kayla.a.fay@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: April 22, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)