NCT07365423 Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
| NCT ID | NCT07365423 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Swiss Cancer Institute |
| Condition | Recurrent Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2026-04-24 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Stefanie Fischer, PD MD
STUDY CHAIR
HOCH Health Ostschweiz
Frequently Asked Questions
Who can join the NCT07365423 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Recurrent Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07365423 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07365423 currently recruiting?
Yes, NCT07365423 is actively recruiting participants. Contact the research team at trials@swisscancerinstitute.ch for enrollment information.
Where is the NCT07365423 trial being conducted?
This trial is being conducted at Baden, Switzerland, Basel, Switzerland, Bellinzona, Switzerland, Chur, Switzerland and 7 additional locations.
Who is sponsoring the NCT07365423 clinical trial?
NCT07365423 is sponsored by Swiss Cancer Institute. The principal investigator is Stefanie Fischer, PD MD at HOCH Health Ostschweiz. The trial plans to enroll 42 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.