Clinical trial · Interventional
Telmisartan in Prostate Cancer
Phase I Non-Randomized, Unblinded, Single-Center Trial of Oral Telmisartan Alone or Combined With Selected Standard of Care Therapies for Prostate Cancer
NCT06168487CI-TRIAL-00118967recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care Regimen | Other | — | UNRESOLVED |
| Telmisartan | Drug | Telmisartan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Telmisartan Alone
- description
- Patients will receive telmisartan alone.
- interventionNames
- Drug: Telmisartan
- type
- EXPERIMENTAL
- label
- Cohort 2: Telmisartan + Standard of Care Regimen
- description
- Patients will receive telmisartan with cabazitaxel or docetaxel without abiraterone), or telmisartan with docetaxal with abirateron or olaparib or rucaparib, or talazoparib plus enzalutamide.
- interventionNames
- Drug: Telmisartan
- Other: Standard of Care Regimen
Primary outcomes (1)
- measure
- Tolerability of oral telmisartan
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (48)
- BACKGROUNDSEER*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
- BACKGROUNDSmith 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. PMID 28314611
- BACKGROUNDChen 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. PMID 36509970
- BACKGROUNDSayegh 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. PMID 34473525
- BACKGROUNDAsim 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. PMID 28851861
- BACKGROUNDSaad 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.