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Recurrent Prostate CancerPhase 2TerbinaProNCT07365423

Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)

A Phase 2 study testing Terbinafine in people with Recurrent Prostate Cancer, run by Swiss Cancer Institute at 11 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
Terbinafine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
11 sitesSwitzerland
Study dates
24 Apr 2026to Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stefanie Röthlisberger, PhD contact

+41 31 389 91 91

trials@swisscancerinstitute.ch

11 sites in 1 country

Switzerland11 sites, 11 recruiting

  • Kantonsspital Baden

    Baden, 5404

    Andreas Erdmann, MD, +41 56 486 27 62, andreas.erdmann@ksb.ch

    Andreas Erdmann, MD

    Recruiting

  • Universitätsspital Basel

    Basel, 4031

    Cyrill A. Rentsch, Prof, +41 61 265 72 80, cyrill.rentsch@usb.ch

    Cyrill A. Rentsch, Prof

    Recruiting

  • EOC - Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

    Thomas Zilli, Prof, +41 91 811 85 13, thomas.zilli@eoc.ch

    Thomas Zilli, Prof

    Recruiting

  • Kantonsspital Graubünden

    Chur, 7000

    Angela Fischer, MD, +41 81 256 66 46, angela.fischer@ksgr.ch

    Angela Fischer, MD

    Recruiting

  • Spital Thurgau AG

    Frauenfeld, 8501

    Regina Woelky, MD, +41 58 144 76 91, regina.woelky@stgag.ch

    Jeanne Godau, MD

    Recruiting

  • Hôpitaux Universitaires Genève HUG

    Geneva, 1211

    Petros Tsantoulis, MD, +41 22 372 98 62, petros.tsantoulis@hcuge.ch

    Petros Tsantoulis, MD

    Recruiting

  • Luzerner Kantonsspital

    Lucerne, 6004

    Christian Rothermundt, MD, +41 41 205 58 60, christian.rothermundt@luks.ch

    Christian Rothermundt, MD

    Recruiting

  • TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil

    Rapperswil, 8640

    Deborah Zihler, MD, +41 55 536 13 00, deborah.zihler@tbz-ost.ch

    Deborah Zihler, MD

    Recruiting

  • HOCH Health Ostschweiz - Kantonsspital St. Gallen

    Sankt Gallen, 9007

    Stefanie Fischer, MD, +41 71 494 11 11, stefanie.fischer@h-och.ch

    Stefanie Fischer, MD

    Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401

    Beat Förster, MD, +41 52 266 2991, beat.foerster@ksw.ch

    Beat Förster, MD

    Recruiting

  • Universitätsspital Zürich USZ

    Zurich, 8091

    Anja Lorch, Prof, +41 43 253 02 50, anja.lorch@usz.ch

    Anja Lorch, Prof

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Terbinafine
Keywords
recurrent prostate cancer, Terbinafine, phase II, drug-repurposing Study
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TerbinafineDrug

    Drug: Terbinafine

Study groups in NCT07365423
Study groupRoleWhat they receive
Stage 1ExperimentalPatients 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
Receives: Drug: Terbinafine
Stage 2ExperimentalAdditional 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
Receives: Drug: Terbinafine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    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.

    Measured: 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.

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

    • 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start24 Apr 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365423
Sponsor's protocol ID
SCI 001
Acronym
TerbinaPro
Status last verified
Jul 2026
First submitted
16 Jan 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Terbinafine in people with Recurrent Prostate Cancer, run by Swiss Cancer Institute at 11 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefanie Röthlisberger, PhD (+41 31 389 91 91, trials@swisscancerinstitute.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate specific antigen Progression-free rate (PSA-PFR) (time frame: From the date of treatment start until 12 weeks after treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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