A Phase 2 interventional study of Terbinafine in Recurrent Prostate Cancer, sponsored by Swiss Cancer Institute. Recruiting at 11 sites in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Swiss Cancer Institute · Phase 2, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 42 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Swiss Cancer Institute is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
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
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
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.
Time frame: From the date of treatment start until 12 weeks after treatment start
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.
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.
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.
Time frame: From the date of treatment start until the end of treatment, estimated up to 336 days after treatment start.
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