Telmisartan in Prostate Cancer

August 18, 2025 updated by: Tyler J Curiel

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to test the tolerability of oral telmisartan given as a single agent or combined with specific standard of care agents in selected participants with PC. Patients will be defined as tolerating telmisartan if they maintain systolic blood pressure >110 mm Hg and are without greater than grade 2 toxicities as defined in the Common Terminology Criteria for Adverse Events v5.1 for at least 60 days total telmisartan treatment.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Health
        • Contact:
          • Rodwell Mabaera, MD
        • Principal Investigator:
          • Rodwell Mabaera, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Telmisartan Alone
Patients will receive telmisartan alone.
Drug: Telmisartan
Patients will be given telmisartan alone or with standard of care chemotherapy.
Other Names:
  • Micardis
Experimental: Cohort 2: Telmisartan + Standard of Care Regimen
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
Patients will be given telmisartan alone or with standard of care chemotherapy.
Other Names:
  • Micardis
Other: Standard of Care Regimen
Standard of Care Regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of oral telmisartan
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in tumor DNA damage
Time Frame: 24 months
Determine if telmisartan increases tumor DNA damage or alters immunity in ways consistent with anti-tumor activity when given alone or with selected standard of care treatments in selected patients with prostate cancer as determined by counting gamma-H2AX foci in tissue sections and peripheral blood mononuclear cells
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of blood prostate specific antigen
Time Frame: 24 months
This exploratory objective is to determine whether telmisartan when given alone or combined with selected standard of care therapies can reduce blood prostate specific antigen or slow its rise in selected patients with prostate cancer as determined by Roche Cobas immunoassay in ng/mL blood
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyler J Curiel

Investigators

  • Principal Investigator: Rodwell Mabaera, MD, Dartmouth Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02002057
  • NCI-2024-07041 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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