Last reviewed · How we verify
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study
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.
Details
| Lead sponsor | Swiss Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 42 |
| Start date | 2026-05 |
| Completion | 2030-10 |
Conditions
- Recurrent Prostate Cancer
Interventions
- Terbinafine
Primary outcomes
- Prostate specific antigen Progression-free rate (PSA-PFR) — From the date of treatment start until 12 weeks after treatment start
The primary endpoint is PSA-PFR at week 12 from start of treatment with Terbinafine. To calculate PSA-PFR at week 12, the Kaplan-Meier estimator of time to PSA progression will be evaluated at 13 weeks after treatment start, to allow 1 week delay in the assessment at 12 weeks.
Countries
Switzerland