Actively Recruiting
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Led by Swiss Cancer Institute · Updated on 2026-04-02
42
Participants Needed
11
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients after definitive treatment for localized prostate cancer and exhaustion of standard curative options such as prostatectomy and adjuvant or salvage radiotherapy; radiotherapy or brachytherapy; previous Stereotactic Body Radiation Therapy (SBRT) allowed if PSA progression confirmed after SBRT
- Non-castrate testosterone levels (≥ 5 nmol/l); previous androgen deprivation therapy allowed if testosterone recovered before study entry
- No distant metastatic disease on CT, bone scan, or PSMA PET CT imaging
- PSMA positive lymph nodes allowed if largest lymph node is < 20 mm below aortic bifurcation or < 10 mm above
- PSA ≥1 ng/ml after radical prostatectomy or ≥2 ng/ml above nadir after primary radiotherapy; rising PSA confirmed by second measurement at least 2 weeks apart
- Patient declines start of androgen deprivation therapy or androgen receptor pathway inhibitor, or is judged not in need of immediate start by physician
You will not qualify if you...
- Known chronic or acute liver disease
- History of systemic lupus erythematosus or any form of lupus including cutaneous, drug-induced, or lupus nephritis
- Pure neuroendocrine or small-cell histologic variant of prostate cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Kantonsspital Baden
Baden, Switzerland, 5404
Actively Recruiting
2
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
EOC - Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Actively Recruiting
4
Kantonsspital Graubünden
Chur, Switzerland, 7000
Actively Recruiting
5
Spital Thurgau AG
Frauenfeld, Switzerland, 8501
Actively Recruiting
6
Hôpitaux Universitaires Genève HUG
Geneva, Switzerland, 1211
Actively Recruiting
7
Luzerner Kantonsspital
Lucerne, Switzerland, 6004
Actively Recruiting
8
TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil
Rapperswil, Switzerland, 8640
Actively Recruiting
9
HOCH Health Ostschweiz - Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
10
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
11
Universitätsspital Zürich USZ
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
C
Christina Müller, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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