RecruitingPhase 1Phase 2NCT06807359

Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System

Open-label Clinical Phase 1/2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer

Sponsor

SpectraCure AB

Enrollment

43 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of focal therapy called photodynamic therapy (PDT) — which uses light-activated drugs to destroy cancer cells — for men with localized, intermediate-risk prostate cancer who want an option that minimizes side effects compared to whole-gland treatments like surgery or radiation. **You may be eligible if...** - You are 18 or older - You have confirmed prostate cancer confined to the prostate (Gleason score 7, meaning either 3+4 or 4+3) - Your PSA level is 15 ng/mL or lower - Your cancer lesion on MRI is small (less than 1.5 cm³) - Your overall physical health is good (ECOG status 0 or 1) - Your kidney, liver, and blood cell counts are adequate **You may NOT be eligible if...** - Your cancer has spread beyond the prostate - There are signs on MRI of cancer extending outside the prostate capsule - You have a suspicious lesion on the opposite side of the prostate - You have previously had prostate surgery, radiation, or hormone therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPhotodynamic Therapy (PDT)

The PDT treatment is provided with the SpectraCure P18 laser light delivery system. 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. The photosensitizer is activated with light of a specific wavelength that is delivered to the tumor via optical fibers. The activated photosensitizer reacts with oxygen to form highly toxic radicals which induce cell death in the tumour. * Phase 1: Light dose escalation. Three subjects will be treated per dose level (20 - 40 J/cm2). If no dose-limiting toxicities occur, dose will be escalated (20 - 40 J/cm2) until the Recommended Phase 2 Dose (RPD2) is established. * Phase 2: Cohort expansion with the RPD2.

DRUGVerteporfin Injection

Verteporfin for Injection (VFI), photosensitizing drug, will be administered intravenously at a dose of 15 mg/m2 body surface area.