Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

TerbinaPro is a phase II drug-repurposing study evaluating oral Terbinafine in patients with biochemical recurrence of prostate cancer after prior local treatment with curative intent. When local salvage strategies have been exhausted, recurrence usually reflects micro-metastatic disease without clearly visible metastases on imaging. Standard therapy with androgen deprivation or androgen-receptor pathway inhibitors can effectively control disease but is associated with substantial side effects and negative impact on quality of life. Terbinafine is a long-licensed, generic antifungal drug that inhibits squalene epoxidase (SQLE), an enzyme that may play a role in prostate cancer progression. Preclinical and limited clinical data suggest potential anti-cancer activity.

NCT Number	NCT07365423
Lead Sponsor	Swiss Cancer Institute
Conditions	Recurrent Prostate Cancer
Enrollment	42 participants
Start Date	2026-04-24
Primary Completion	2028-02 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-16