Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) (TerbinaPro)

March 27, 2026 updated by: Swiss Cancer Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

About 20-50% of patients with prostate cancer will develop biochemical recurrence within 10 years after local treatment with initial curative intent. After exhaustion of local salvage strategies such as radiotherapy to the prostate bed, biochemical recurrence usually indicates micro metastatic locoregional or distant disease, mostly no longer amenable to curative strategies. Evidence on how to treat these patients without clearly visible metastatic disease on imaging is very limited. Eventually, patients will be started on androgen deprivation therapy and/or androgen-receptor pathway inhibitors. These treatments however have well-known side effects and negative impact on quality of life such as causing hot flushes, reduction of bone and muscle mass and affecting sexual function and psychological wellbeing. Many patients therefore have an interest to postpone initiation of androgen deprivation and new treatment options are needed. Terbinafine is a long-licensed and generic anti-fungal drug used to treat fungal infections of nails and skin with a very favorable side-effect profile. Its mode of action is inhibition of the fungal enzyme squalene epoxidase (SQLE) which results in accumulation of squalene and consecutive fungal cell death. SQLE is also present in mammalian cells and a growing amount of preclinical and limited clinical study data suggests that SQLE may play a role in development and progression of different cancer types. In prostate cancer, overexpression of SQLE has been documented and shown to be associated with adverse outcomes. Tissue culture and xenograft models show inhibition of prostate cancer cells by Terbinafine, including models resistant to androgen-receptor pathway inhibitors. Limited clinical and retrospective population-based data also suggest activity of Terbinafine in patients with prostate cancer. However, so far, the drug has not been tested systematically in prostate cancer patients and based on our knowledge, no such trials are currently ongoing. TerbinaPro is a drug repurposing phase II study to assess activity of Terbinafine in biochemical recurrence of prostate cancer.

The primary objective of the trial is to demonstrate efficacy of Terbinafine in biochemically recurrent prostate cancer. Secondary objectives are exploration of an active oncological dose and safety of treatment.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Recruiting
        • Kantonsspital Baden
        • Contact:
        • Principal Investigator:
          • Andreas Erdmann, MD
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
        • Contact:
        • Principal Investigator:
          • Cyrill A. Rentsch, Prof
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • EOC - Istituto Oncologico della Svizzera Italiana
        • Principal Investigator:
          • Thomas Zilli, Prof
        • Contact:
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden
        • Contact:
        • Principal Investigator:
          • Angela Fischer, MD
      • Frauenfeld, Switzerland, 8501
        • Recruiting
        • Spital Thurgau AG
        • Contact:
        • Principal Investigator:
          • Jeanne Godau, MD
      • Geneva, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires Genève HUG
        • Principal Investigator:
          • Petros Tsantoulis, MD
        • Contact:
      • Lucerne, Switzerland, 6004
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
        • Principal Investigator:
          • Christian Rothermundt, MD
      • Rapperswil, Switzerland, 8640
        • Recruiting
        • TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil
        • Contact:
        • Principal Investigator:
          • Deborah Zihler, MD
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • HOCH Health Ostschweiz - Kantonsspital St. Gallen
        • Principal Investigator:
          • Stefanie Fischer, MD
        • Contact:
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Kantonsspital Winterthur
        • Principal Investigator:
          • Beat Förster, MD
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitätsspital Zürich USZ
        • Contact:
        • Principal Investigator:
          • Anja Lorch, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1
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
Drug: Terbinafine
Experimental: Stage 2

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
Drug: Terbinafine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate specific antigen Progression-free rate (PSA-PFR)
Time Frame: 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.
From the date of treatment start until 12 weeks after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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.

PFS will be calculated from treatment start until one of the following events, whichever occurs first:

  • Death from any cause
  • Presence of unequivocal radiographic progression as assessed by the local investigator
  • Presence of PSA progression
  • Presence of clinical/symptomatic progression Patients without an event will be censored at the date of the last available assessment showing no event before the start of the subsequent treatment, if any.
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)
Time Frame: From the date of treatment start until the end of treatment, estimated up to 336 days after treatment start.
  • 30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA).
  • 50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA).
  • 90% PSA response is defined as a decrease in PSA level of at least 90% (compared to baseline PSA).

Best PSA response is defined as the percentage of change in PSA from baseline to the maximum decline in PSA at any point under treatment. If there is a steady increase after baseline, the best response is defined as the percentage of change in PSA from baseline to the minimum increase in PSA at any point under treatment. Baseline is defined as the latest recorded PSA measurement prior to the first dose of treatment.
From the date of treatment start until the end of treatment, estimated up to 336 days after treatment start.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Cancer Institute

Investigators

  • Study Chair: Stefanie Fischer, PD MD, HOCH Health Ostschweiz
  • Study Director: Richard Cathomas, Prof, Cantonal Hospital Graubünden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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