This study is testing a treatment called Photodynamic Therapy (PDT) for men with primary localized prostate cancer. PDT uses the SpectraCure P18 system along with a drug called Verteporfin for Injection (VFI). During the treatment, you would receive VFI intravenously (into a vein), and then optical fibers would be inserted into your prostate under general anesthesia to deliver light. The goal is to see how safe this treatment is, find the best light dose, and determine how well it works. The study is looking for men aged 18 or older with prostate cancer that has not spread, diagnosed within the last 9 months. The study will follow participants for 18 months to check the main results, with a total follow-up of 36 months.

Study design

This interventional study plans to enroll 43 participants. It has two parts: an initial phase to find the safest and most effective light dose, followed by a phase to confirm its effectiveness and safety.

What's involved

You would undergo Photodynamic Therapy (PDT) under general anesthesia, which involves an intravenous injection of Verteporfin and insertion of optical fibers into the prostate. You will be followed for 18 months, with a long-term follow-up extending to 36 months.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 18 months to determine the primary outcomes, with an additional 18 months for long-term follow-up, totaling 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.