Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
ConditionRecurrent Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSwiss Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Terbinafine
DrugDrug: Terbinafine
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Stage 1Experimental treatment 1 intervention
Group B: Stage 2Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
From the date of treatment start until 12 weeks after treatment startSecondary outcomes
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.
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.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.
Time frame
From the date of treatment start until the end of treatment, estimated up to 336 days after treatment start.Sponsors and contacts
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Source ClinicalTrials.gov