Terbinafine for prostate cancer with rising PSA after local treatment
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study
This phase II test gives oral terbinafine to men with biochemical recurrence after definitive local therapy and no visible metastases to see if it slows PSA rise and delays starting hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Swiss Cancer Institute Academic / other |
| Drugs / interventions | Radiation |
| Locations | 11 sites (Baden and 10 other locations) |
| Trial ID | NCT07365423 on ClinicalTrials.gov |
What this trial studies
TerbinaPro is a phase II, drug-repurposing trial that gives oral terbinafine to men who have biochemical recurrence of prostate cancer after definitive local treatment but no detectable metastases on CT, bone scan, or PSMA PET. Participants must have non-castrate testosterone levels and have exhausted standard curative salvage options; small PSMA-positive lymph nodes within specified size limits may be allowed. The trial monitors PSA kinetics, safety, and imaging over time while patients remain off routine androgen-deprivation therapy. The approach is based on preclinical and limited clinical data suggesting that terbinafine’s inhibition of the enzyme SQLE could slow prostate cancer progression.
Who should consider this trial
Good fit: Men with rising PSA after definitive local prostate cancer treatment, recovered non-castrate testosterone, no visible distant metastases on conventional imaging or PSMA PET, and for whom local curative options are exhausted.
Not a fit: Patients with clear distant metastatic disease on imaging, persistent castrate-level testosterone, known terbinafine intolerance, or significant active liver disease are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, terbinafine could slow PSA progression and delay the need for androgen-deprivation therapy, reducing exposure to its side effects.
How similar studies have performed: Preclinical studies and limited clinical observations suggest SQLE inhibition may have anti-cancer effects, but human evidence in prostate cancer is sparse and this repurposing approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) CT. * Patients with PSMA positive lymph nodes on PSMA PET CT can still be included if the short axis of the largest lymph node is \< 20 mm for lymph nodes below aortic bifurcation or \< 10 mm above the aortic bifurcation. * PSA of ≥1 ng/ml after radical prostatectomy or ≥2 ng/ml above the nadir (with recovered testosterone) after primary radiotherapy; confirmation of rising PSA in at least a second measurement at least 2 weeks apart * Patient declining start of ADT and /or an androgen receptor pathway inhibitor (ARPI) and/or judged as not in need of immediate ADT/ARPI start by treating physician Key Exclusion Criteria: * Pre-existing known chronic or acute liver disease * Known history of systemic lupus erythematosus or any form of lupus (including cutaneous, drug-induced, or lupus nephritis) * Pure neuroendocrine/small-cell histologic variant of prostate cancer
Where this trial is running
Baden and 10 other locations
- Kantonsspital Baden — Baden, Switzerland (Recruiting)
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- EOC - Istituto Oncologico della Svizzera Italiana — Bellinzona, Switzerland (Recruiting)
- Kantonsspital Graubünden — Chur, Switzerland (Recruiting)
- Spital Thurgau AG — Frauenfeld, Switzerland (Recruiting)
- Hôpitaux Universitaires Genève HUG — Geneva, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil — Rapperswil, Switzerland (Recruiting)
- HOCH Health Ostschweiz - Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- Universitätsspital Zürich USZ — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Christina Müller, PhD
- Email: trials@swisscancerinstitute.ch
- Phone: +41 31 389 91 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.