Terbinafine for prostate cancer with rising PSA after local treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TerbinaPro is a phase II, drug-repurposing trial that gives oral terbinafine to men who have biochemical recurrence of prostate cancer after definitive local treatment but no detectable metastases on CT, bone scan, or PSMA PET. Participants must have non-castrate testosterone levels and have exhausted standard curative salvage options; small PSMA-positive lymph nodes within specified size limits may be allowed. The trial monitors PSA kinetics, safety, and imaging over time while patients remain off routine androgen-deprivation therapy. The approach is based on preclinical and limited clinical data suggesting that terbinafine’s inhibition of the enzyme SQLE could slow prostate cancer progression.

Why it matters

Who can join: the full rules

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

Where it's running

• Kantonsspital Baden
  Baden, Switzerland Recruiting
• Universitätsspital Basel
  Basel, Switzerland Recruiting
• EOC - Istituto Oncologico della Svizzera Italiana
  Bellinzona, Switzerland Recruiting
• Kantonsspital Graubünden
  Chur, Switzerland Recruiting
• Spital Thurgau AG
  Frauenfeld, Switzerland Recruiting
• Hôpitaux Universitaires Genève HUG
  Geneva, Switzerland Recruiting

Study contacts

• Study coordinator: Stefanie Röthlisberger, PhD
• Email: trials@swisscancerinstitute.ch
• Phone: +41 31 389 91 91

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.