This phase I trial tests the safety and side effects of telmisartan, and compares how well it works alone to the combination with selected standard of care treatments in patients with prostate cancer. Telmisartan, an angiotensin II receptor blocker, may increase the damaging effect of chemotherapy on tumor deoxyribonucleic acid (DNA) and has been shown to increase in tumor cell DNA damage when used alone. Chemotherapy drugs, such as cabazitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Olaparib, rucaparib, and talazoparib are poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors. PARP is a protein that helps repair damaged DNA. Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Enzalutamide and abiraterone are androgen receptor inhibitors. Androgen receptor inhibitors work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving telmisartan may be safe, tolerable, and/or effective alone or in combination with standard of care treatments in patients with prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06168487.
Locations matching your search criteria
United States
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterStatus: Active
Contact: Rodwell Mabaera
Phone: 603-650-4344
PRIMARY OBJECTIVE:
I. To test the tolerability of oral telmisartan given as a single agent or combined with specific standard of care (SOC) agents in selected participants with prostate cancer (PC).
SECONDARY OBJECTIVES:
I. To determine if telmisartan increases tumor DNA damage or alters immunity in ways consistent with anti-tumor activity when given alone or with selected SOC treatments in selected participants with PC.
II. To assess prostate specific antigen (PSA) level in blood for treatment response.
EXPLORATORY OBJECTIVE:
I. To determine whether telmisartan when given alone or combined with selected SOC therapies can reduce blood prostate specific antigen or slow its rise in selected participants with PC.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive telmisartan orally (PO) once daily (QD) for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients that have been on a stable telmisartan dose for at least 2 months may start SOC therapies as necessary per treating oncologist. Patients undergo blood sample collection on study. Patients may undergo optional collection of leftover tissue from SOC biopsy on study.
COHORT II: Patients receive telmisartan PO QD for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also receive cabazitaxel, docetaxel with or without abiraterone, olaparib, rucaparib, or enzalutamide and talazoparib per SOC. Patients undergo blood sample collection on study. Patients may undergo optional collection of leftover tissue from SOC biopsy on study.
After completion of study treatment, patients are followed up at 1 month.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorRodwell Mabaera
