Condition: Prostate Cancer · Sponsor: SpectraCure AB
The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, together with verteporfin for injection (VFI) as photosensitizer, for the treatment of primary localized prostate cancer. The study will be divided into two parts, with Phase I, dose-escalation, to study safety and establish an effective light dose, followed by Phase II, cohort expansion, to evaluate clinical efficacy and confirm safety/tolerability. The subjects will be followed for a period of 18 months to determine the primary outcome. The long-term follow-up is an additional 18 months, i.e. a total of 36 months. Interstitial Photodynamic Therapy (PDT) will be performed during general anesthesia. Optical fibers will be inserted into the prostate with a transperineal approach using transrectal ultrasound guidance. The intent is to deliver an adequate light dose throughout the prostate. Subjects will receive VFI intravenously, approximately 60-90 minutes prior to light delivery.
This description comes directly from the study's public registry record.
Kristina Holst · +46708233630 · clinical@spectracure.com
Always discuss trial participation with your own doctor first.
| Memorial Sloan Kettering Cancer Center | New York, New York, United States | Recruiting |
| Klinik für Urologie, Universitätsklinikum Köln | Cologne, Germany | Recruiting |
| Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock | Rostock, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06807359