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 metasta
| Condition(s) | Recurrent Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Key Inclusion Criteria: * Patients after definitive treatment for localized prostate cancer and exhaustion of standard curative options (i.e. after prostatectomy and adjuvant /salvage radiotherapy; definite radiotherapy, brachytherapy; additional previous Stereotactic Body Radiation Therapy (SBRT) to treat visible oligometastatic disease also allowed as long as confirmed Prostate-specific antigen (PSA) progression is present after SBRT) * Non-castrate levels of testosterone (≥ 5 nmol/l; previous androgen deprivation therapy (ADT) allowed as long as testosterone levels have recovered before study entry) * No evidence of distant metastatic disease on conventional imaging (Computed Tomography (CT) and bone scan) or Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) C |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Swiss Cancer Institute |
| Locations | Baden, Switzerland; Basel, Switzerland; Bellinzona, Switzerland; Chur, Switzerland; Frauenfeld, Switzerland; Geneva, Switzerland (+5 more sites) |
| Start date | 2026-05 |
| NCT ID | NCT07365423 |
| Official listing | https://clinicaltrials.gov/study/NCT07365423 |