drugset / Trial / NCT07365423

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

NCT07365423

Phase 2 Recruiting 42 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-04-24
Primary completion
2028-02
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Terbinafine Small molecule 250 mg Oral
Subject Terbinafine Small molecule 500 mg Oral
Subject Terbinafine Small molecule 1000 mg Oral

Indications