Terbinafine for the treatment of patients with prostate cancer who have a biochemical recurrence; the drug Terbinafine is used in this phase 2 study for a different medical purpose than previously usual
Descrizione riassuntiva dello studio
Most men with a biochemical recurrence are offered a therapy that suppresses male sex hormones. This often allows the growth of cancer cells to be stopped for a longer period of time. However, this treatment often has side effects, such as hot flashes, bone loss, and sexual function disturbances. Therefore, new treatment methods for men with a biochemical recurrence are being sought. Terbinafine is a drug used to treat fungal infections of the nails and skin. Various study results suggest that Terbinafine may also inhibit the growth of prostate cancer cells. However, Terbinafine has not yet been tested for cancer treatment in patients with prostate cancer. In our study, we want to investigate how Terbinafine works in men whose prostate cancer shows signs of activity again after initial treatment.
(BASEC)
Intervento studiato
Patients participating in the study take the drug Terbinafine in tablet form daily. The dosage is 250 mg (one tablet in the morning), 500 mg (one tablet in the morning and one in the evening), or 1000 mg (two tablets in the morning and two in the evening). The treatment lasts a maximum of 48 weeks. This period is divided into 12 treatment cycles of 4 weeks each. After the end of treatment with Terbinafine, study participants will be regularly monitored for one year.
(BASEC)
Malattie studiate
Prostate cancer that has been treated locally and is now experiencing a biochemical recurrence (elevated PSA levels in the blood)
(BASEC)
Study participants must meet various requirements. The most important include: • Age: at least 18 years • The participant has prostate cancer that has been treated locally with the aim of cure; elevated PSA levels have now been measured in the blood. • The participant does not wish to start treatment immediately to suppress sex hormones. (BASEC)
Criteri di esclusione
Not all men with prostate cancer and a biochemical recurrence can participate in the study. The main criteria for exclusion include: • The patient has a chronic or acute liver disease. • The patient has other serious illnesses, such as severe heart or lung disease, other cancers, or active infections (Hepatitis B or C, HIV infection, etc.) (BASEC)
Luogo dello studio
Basilea, Bellinzona, Chur, Ginevra, Lugano, Luzern, San Gallo, Winterthur, Zurigo, Altro
(BASEC)
Baden, Frauenfeld, Münsterlingen, Rapperswil
(BASEC)
Sponsor
Swiss Cancer Institute, BE
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Stefanie Röthlisberger
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Informazioni generali
HOCH Health OstschweizCantonal Hospital Graubnden
+41 31 389 91 91
trials@clutterswisscancerinstitute.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
05.03.2026
(BASEC)
ID di studio ICTRP
NCT07365423 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Terbinafine for biochemically recurrent prostate cancer (TerbinaPro) - A phase II drug-repurposing Study (BASEC)
Titolo accademico
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study (ICTRP)
Titolo pubblico
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) (ICTRP)
Malattie studiate
Recurrent Prostate Cancer (ICTRP)
Intervento studiato
Drug: Terbinafine (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 (ICTRP)
non disponibile
Endpoint primari e secondari
Prostate specific antigen Progression-free rate (PSA-PFR) (ICTRP)
Progression-free survival (PFS);Prostate-specific antigen (PSA) response (30%, 50%, 90% and best) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Stefanie Fischer, PD MDRichard Cathomas, ProfChristina Mller, PhD, trials@swisscancerinstitute.ch, +41 31 389 91 91, HOCH Health OstschweizCantonal Hospital Graubnden (ICTRP)
ID secondari
SCI 001 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07365423 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile