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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Basel, Bellinzona, Chur, Genf, Lugano, Luzern, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Baden, Frauenfeld, Münsterlingen, Rapperswil
(BASEC)
Sponsor
Swiss Cancer Institute, BE
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Stefanie Röthlisberger
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Allgemeine Auskünfte
HOCH Health OstschweizCantonal Hospital Graubnden
+41 31 389 91 91
trials@clutterswisscancerinstitute.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.03.2026
(BASEC)
ICTRP Studien-ID
NCT07365423 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Terbinafine for biochemically recurrent prostate cancer (TerbinaPro) - A phase II drug-repurposing Study (BASEC)
Wissenschaftlicher Titel
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study (ICTRP)
Öffentlicher Titel
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) (ICTRP)
Untersuchte Krankheit(en)
Recurrent Prostate Cancer (ICTRP)
Untersuchte Intervention
Drug: Terbinafine (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Prostate specific antigen Progression-free rate (PSA-PFR) (ICTRP)
Progression-free survival (PFS);Prostate-specific antigen (PSA) response (30%, 50%, 90% and best) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Stefanie Fischer, PD MDRichard Cathomas, ProfChristina Mller, PhD, trials@swisscancerinstitute.ch, +41 31 389 91 91, HOCH Health OstschweizCantonal Hospital Graubnden (ICTRP)
Sekundäre IDs
SCI 001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07365423 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar