NCT07365423

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
54mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

January 16, 2026

Last Update Submit

March 27, 2026

Conditions

Recurrent Prostate Cancer

Keywords

recurrent prostate cancerTerbinafinephase IIdrug-repurposing Study

Outcome Measures

Primary Outcomes (1)

  • Prostate specific antigen Progression-free rate (PSA-PFR)

    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.

    From the date of treatment start until 12 weeks after treatment start

Secondary Outcomes (2)

  • Progression-free survival (PFS)

    From the date of treatment start until the date of progression or death from any cause, assessed up to 1 year after end of treatment.

  • Prostate-specific antigen (PSA) response (30%, 50%, 90% and best)

    From the date of treatment start until the end of treatment, estimated up to 336 days after treatment start.

Study Arms (2)

Stage 1

EXPERIMENTAL

Patients will be randomized in a 1:1:1 ratio for a total of 9 patients per dose level to either the standard dose (250mg) or an escalated dose (500mg or 1000mg).Treatment duration: up to 12 cycles of 28 days

Drug: Terbinafine

Stage 2

EXPERIMENTAL

Additional patients will be enrolled in stage II, at a selected dose level, based on the results obtained in Stage I. Treatment duration: up to 12 cycles of 28 days

Drug: Terbinafine

Interventions

TerbinafineDRUG

Drug: Terbinafine

Stage 1Stage 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kantonsspital Baden

Baden, 5404, Switzerland

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

EOC - Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

Spital Thurgau AG

Frauenfeld, 8501, Switzerland

RECRUITING

Hôpitaux Universitaires Genève HUG

Geneva, 1211, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

RECRUITING

TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil

Rapperswil, 8640, Switzerland

RECRUITING

HOCH Health Ostschweiz - Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

RECRUITING

Universitätsspital Zürich USZ

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Stefanie Fischer, PD MD

    HOCH Health Ostschweiz

    STUDY CHAIR

  • Richard Cathomas, Prof

    Cantonal Hospital Graubünden

    STUDY DIRECTOR

Central Study Contacts

Christina Müller, PhD

CONTACT

+41 31 389 91 91trials@swisscancerinstitute.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label, two-stage design with three dose levels Patients with biochemically recurrent Prostate Cancer (PCa) after exhaustion of local treatment options with curative intent with non-castrate levels of testosterone will be randomized to treatment with Terbinafine either at the licensed dose of 250 mg daily or an escalated dose of 500 mg or 1000 mg daily for up to 12 cycles, consisting of 28 days each. In stage I, all three dose levels will be opened and enrolled in parallel. Additional patients will be enrolled in stage II, at a selected dose level, based on the results obtained in Stage I.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

October 1, 2030

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

CH(11)