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NCT07365423Recruiting

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

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.

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

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 2
Study type
Interventional
Countries
Switzerland
Sponsor
Swiss Cancer Institute(Other)
Protocol no.
SCI 001
Conditions
Recurrent Prostate Cancer
Interventions
Drug

Treatments studied

  • Terbinafine

Locations · 11

  • Baden, SwitzerlandKantonsspital BadenRecruiting at this site
  • Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
  • Bellinzona, SwitzerlandEOC - Istituto Oncologico della Svizzera ItalianaRecruiting at this site
  • Chur, SwitzerlandKantonsspital GraubündenRecruiting at this site
  • Frauenfeld, SwitzerlandSpital Thurgau AGRecruiting at this site
  • Geneva, SwitzerlandHôpitaux Universitaires Genève HUGRecruiting at this site
  • Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
  • Rapperswil, SwitzerlandTBZO Tumor- und BrustZentrum Ostschweiz - RapperswilRecruiting at this site
  • Sankt Gallen, SwitzerlandHOCH Health Ostschweiz - Kantonsspital St. GallenRecruiting at this site
  • Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
  • Zurich, SwitzerlandUniversitätsspital Zürich USZRecruiting at this site

In total, worldwide, all 11 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 28, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.