Actively Recruiting
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study
Led by Swiss Cancer Institute · Updated on 2026-04-02
42
Participants Needed
11
Research Sites
139 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating oral Terbinafine in patients with biochemical recurrence of prostate cancer after prior local treatment intended to cure the disease. This phase II drug-repurposing study focuses on patients who have exhausted local salvage treatments and have no visible metastases on imaging. Standard therapies like androgen deprivation or androgen-receptor pathway inhibitors can control disease but often cause significant side effects and reduce quality of life. Terbinafine, a long-licensed antifungal drug, inhibits an enzyme that may influence prostate cancer progression, with early data suggesting possible anti-cancer effects. Participants will be randomized to receive either a standard dose (250 mg) or an escalated dose (500 mg or 1000 mg) of Terbinafine, taken orally in cycles of 28 days, for up to 12 cycles. Following initial dose evaluation in Stage 1, additional patients may be enrolled in Stage 2 at the selected dose based on prior results. The study assesses the drug's activity and explores the best active dose and safety in this patient group. During the study, researchers will monitor prostate specific antigen (PSA) progression-free rate up to 12 weeks after treatment start as the primary outcome. They will also evaluate progression-free survival up to one year after treatment ends and measure PSA responses. Participants will undergo regular assessments including imaging and lab tests to track disease status and treatment effects. The study includes safety monitoring and lasts through treatment cycles and follow-up periods.
CONDITIONS
Brief Title
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with biochemical recurrence of prostate cancer after definitive treatment and exhaustion of local curative options
- Non-castrate testosterone levels (≥ 5 nmol/l), including those with prior androgen deprivation therapy if testosterone has recovered
- No distant metastatic disease on conventional imaging (CT and bone scan) or PSMA PET CT
- PSMA positive lymph nodes allowed if size criteria are met (largest lymph node < 20 mm below aortic bifurcation or < 10 mm above)
- PSA ≥ 1 ng/ml after prostatectomy or ≥ 2 ng/ml above nadir after radiotherapy with confirmed rising PSA
- Patient declines or is judged not in need of immediate androgen deprivation or androgen receptor pathway inhibitor therapy
You will not qualify if you...
- Pre-existing 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive Terbinafine treatment in cycles to assess its effect on biochemical recurrence of prostate cancer.
Up to 12 monthly visits for treatment and assessments
Duration - Up to 1 year after end of treatment
Participants are monitored for progression-free survival and safety after completing treatment.
Periodic visits during follow-up up to 1 year
Trial Site Locations
Total: 11 locations
1
Kantonsspital Baden
Baden, Switzerland, 5404
Actively Recruiting
2
Universitätsspital Basel
Basel, Switzerland, 4031
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3
EOC - Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
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4
Kantonsspital Graubünden
Chur, Switzerland, 7000
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5
Spital Thurgau AG
Frauenfeld, Switzerland, 8501
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6
Hôpitaux Universitaires Genève HUG
Geneva, Switzerland, 1211
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7
Luzerner Kantonsspital
Lucerne, Switzerland, 6004
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8
TBZO Tumor- und BrustZentrum Ostschweiz - Rapperswil
Rapperswil, Switzerland, 8640
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9
HOCH Health Ostschweiz - Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
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10
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
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11
Universitätsspital Zürich USZ
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
C
Christina Müller, PhD
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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