NCT06807359

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: SpectraCure AB · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2025-01-06
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-02-04
• Last updated: 2025-12-18

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study
• FDA-regulated device study