Phase II Study of Oral Terbinafine for Men With Biochemical Recurrence of Prostate Cancer After Local Treatment

What this Trial Is About

Researchers are evaluating the use of oral Terbinafine in patients who have biochemical recurrence of prostate cancer after prior local treatments intended to cure the disease. This phase II drug-repurposing study focuses on patients whose cancer has returned but without clear metastases visible on imaging. Standard treatments involve androgen deprivation or androgen-receptor pathway inhibitors, which can control the disease but often cause significant side effects and affect quality of life. Terbinafine, originally an antifungal drug, shows potential in inhibiting an enzyme SQLE that may contribute to prostate cancer progression, making it a candidate for further study in this setting. Participants will be randomly assigned to receive one of three doses of Terbinafine the standard 250 mg or escalated doses of 500 mg or 1000 mg daily. The treatment is given in cycles of 28 days and can last up to 12 cycles. The study includes two stages the first stage evaluates different dose levels with nine patients per dose group, and the second stage enrolls additional patients at the selected dose based on initial results, also for up to 12 treatment cycles. During the study, participants will have regular assessments to monitor prostate-specific antigen PSA progression and response, as well as overall progression-free survival up to one year after treatment ends. Researchers will also evaluate the safety and tolerability of Terbinafine. Participants will be monitored from the start of treatment through 12 weeks for primary outcomes, with additional follow-up extending to one year. This study aims to explore a new treatment option that might delay the need for androgen deprivation therapy and its associated side effects.

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)