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New treatment option for Recurrent Prostate Cancer
Official title Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
ClinicalTrials.gov ID: NCT07365423
What this study is testing
What is Terbinafine?
Terbinafine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for recurrent prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients after definitive treatment for localized prostate cancer and exhaustion of standard curative options (i.e. after prostatectomy and adjuvant...
- Non-castrate levels of testosterone (≥ 5 nmol/l; previous androgen deprivation therapy (ADT) allowed as long as testosterone levels have recovered...
- No evidence of distant metastatic disease on conventional imaging (Computed Tomography (CT) and bone scan) or Prostate-Specific Membrane Antigen...
- 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...
- PSA of ≥1 ng/ml after radical prostatectomy or ≥2 ng/ml above the nadir (with recovered testosterone) after primary radiotherapy; confirmation of...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baden, Switzerland
- Basel, Switzerland
- Bellinzona, Switzerland
- Chur, Switzerland
- Frauenfeld, Switzerland
- Geneva, Switzerland
- Lucerne, Switzerland
- Rapperswil, Switzerland
- Sankt Gallen, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baden, Switzerland; Basel, Switzerland; Bellinzona, Switzerland; Chur, Switzerland; Frauenfeld, Switzerland; Geneva, Switzerland and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.