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Prostate CancerPhase 1NCT06168487

Telmisartan in Prostate Cancer

A Phase 1 study testing Telmisartan in people with Prostate Cancer, run by Tyler J Curiel at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Telmisartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
22 Apr 2024to 1 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Dartmouth Health

    Lebanon, New Hampshire, 03756

    Rodwell Mabaera, MD

    Rodwell Mabaera, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Telmisartan, Standard of Care Regimen
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelmisartanDrug

    Also called Micardis

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

  • Standard of Care RegimenOther

    Standard of Care Regimen

Study groups in NCT06168487
Study groupRoleWhat they receive
Cohort 1: Telmisartan AloneExperimentalPatients will receive telmisartan alone.
Receives: Drug: Telmisartan
Cohort 2: Telmisartan + Standard of Care RegimenExperimentalPatients will receive telmisartan with cabazitaxel or docetaxel without abiraterone), or telmisartan with docetaxal with abirateron or olaparib or rucaparib, or talazoparib plus enzalutamide.
Receives: Drug: Telmisartan; Other: Standard of Care Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (1)
  1. Increase in tumor DNA damage

    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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start22 Apr 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06168487
Sponsor's protocol ID
STUDY02002057
Other IDs
NCI-2024-07041
Status last verified
May 2026
First submitted
4 Dec 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; 2023 Apr 19. Available from: https://seer.cancer.gov/statistics-network/explorer/. Data source(s): SEER Incidence Data, November 2022 Submission (1975-2020), SEER 22 registries. updated: 2023 Jun 8. Accessed Oct 5, 2023

  • Smith MR, Saad F, Rathkopf DE, Mulders PFA, de Bono JS, Small EJ, Shore ND, Fizazi K, Kheoh T, Li J, De Porre P, Todd MB, Yu MK, Ryan CJ. Clinical Outcomes from Androgen Signaling-directed Therapy after Treatment with Abiraterone Acetate and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Jul;72(1):10-13. doi: 10.1016/j.eururo.2017.03.007. Epub 2017 Mar 15.

    PubMed 28314611
  • Chen K, O'Brien J, McVey A, Jenjitranant P, Kelly BD, Kasivisvanathan V, Lawrentschuk N, Murphy DG, Azad AA. Combination treatment in metastatic prostate cancer: is the bar too high or have we fallen short? Nat Rev Urol. 2023 Feb;20(2):116-123. doi: 10.1038/s41585-022-00669-z. Epub 2022 Dec 12.

    PubMed 36509970
  • Sayegh N, Swami U, Agarwal N. Recent Advances in the Management of Metastatic Prostate Cancer. JCO Oncol Pract. 2022 Jan;18(1):45-55. doi: 10.1200/OP.21.00206. Epub 2021 Sep 2.

    PubMed 34473525
  • Asim M, Tarish F, Zecchini HI, Sanjiv K, Gelali E, Massie CE, Baridi A, Warren AY, Zhao W, Ogris C, McDuffus LA, Mascalchi P, Shaw G, Dev H, Wadhwa K, Wijnhoven P, Forment JV, Lyons SR, Lynch AG, O'Neill C, Zecchini VR, Rennie PS, Baniahmad A, Tavare S, Mills IG, Galanty Y, Crosetto N, Schultz N, Neal D, Helleday T. Synthetic lethality between androgen receptor signalling and the PARP pathway in prostate cancer. Nat Commun. 2017 Aug 29;8(1):374. doi: 10.1038/s41467-017-00393-y.

    PubMed 28851861
  • Saad F, Clarke NW, Oya M, Shore N, Procopio G, Guedes JD, Arslan C, Mehra N, Parnis F, Brown E, Schlurmann F, Joung JY, Sugimoto M, Sartor O, Liu YZ, Poehlein C, Barker L, Del Rosario PM, Armstrong AJ. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): final prespecified overall survival results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Oct;24(10):1094-1108. doi: 10.1016/S1470-2045(23)00382-0. Epub 2023 Sep 12.

    PubMed 37714168
  • Murray C, Bai H, Ontiveros CO, et al. Pharmacologic tumor PDL1 depletion as a novel approach to overcome treatment resistance. The Journal of Immunology. 2023;210(1_Supplement):230.08-230.08. doi:10.4049/jimmunol.210.Supp.230.08

  • Uemura H, Miyoshi Y, Ishiguro H, Nakaigawa N, Noguchi K, Kubota Y. Effectiveness of angionten II receptor blocker (ARB), candesartan, in the treatment of hormone refractory prostate cancer (HRPC). presented at: 2004 ASCO Annual Meeting; 2004

  • Wang C, Wang WB. Telmisartan Induces Osteosarcoma Cells Growth Inhibition and Apoptosis Via Suppressing mTOR Pathway. Open Life Sci. 2018 Jul 5;13:242-249. doi: 10.1515/biol-2018-0029. eCollection 2018 Jan.

    PubMed 33817089
  • Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22.

    PubMed 26903579
  • Jensterle M, Janez A, Vrtovec B, Meden-Vrtovec H, Pfeifer M, Prezelj J, Kocjan T. Decreased androgen levels and improved menstrual pattern after angiotensin II receptor antagonist telmisartan treatment in four hypertensive patients with polycystic ovary syndrome: case series. Croat Med J. 2007 Dec;48(6):864-70. doi: 10.3325/cmj.2007.6.864.

    PubMed 18074422
  • McAlister FA; Renin Angiotension System Modulator Meta-Analysis Investigators. Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers are beneficial in normotensive atherosclerotic patients: a collaborative meta-analysis of randomized trials. Eur Heart J. 2012 Feb;33(4):505-14. doi: 10.1093/eurheartj/ehr400. Epub 2011 Oct 31.

    PubMed 22041554
  • Galle J. Reduction of proteinuria with angiotensin receptor blockers. Nat Clin Pract Cardiovasc Med. 2008 Jul;5 Suppl 1:S36-43. doi: 10.1038/ncpcardio0806.

    PubMed 18580865
  • Qaisar R, Kamli H, Karim A, Muhammad T, Ahmad F, Shaikh A. Angiotensin Receptor Blockers Restore Skeletal Muscle in Patients with Chronic Obstructive Pulmonary Disease. Arch Med Res. 2023 Nov;54(7):102890. doi: 10.1016/j.arcmed.2023.102890. Epub 2023 Sep 21.

    PubMed 37741098
  • Fang T, Zhang J, Zuo T, Wu G, Xu Y, Yang Y, Yang J, Shen Q. Chemo-Photothermal Combination Cancer Therapy with ROS Scavenging, Extracellular Matrix Depletion, and Tumor Immune Activation by Telmisartan and Diselenide-Paclitaxel Prodrug Loaded Nanoparticles. ACS Appl Mater Interfaces. 2020 Jul 15;12(28):31292-31308. doi: 10.1021/acsami.0c10416. Epub 2020 Jul 1.

    PubMed 32551473

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telmisartan in people with Prostate Cancer, run by Tyler J Curiel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kayla Fay (603-650-5000, kayla.a.fay@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of oral telmisartan (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06168487, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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