NCT03067051

Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: SpectraCure AB · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.

Detailed description

In 2011, more than 200,000 men in North America alone were diagnosed with cancer of the prostate, which makes it one of the most common cancer types. It affects the lives of the subjects in many ways. After treatment the subjects PSA levels are being closely monitored to detect potential recurrence. A high number of subjects will get recurrent prostate cancer. The treatment options for recurrent cancer are more limited than for primary tumors as secondary treatment partly depends on which treatment the subject has previously undergone. Treatment of recurrent prostate cancer may, depending on the standard treatment of the primary disease, include the following: * Radiation therapy. * Prostatectomy for subjects initially treated with radiation therapy. * Hormone therapy. * Pain medication, external radiation therapy, internal radiation therapy with radioisotopes such as strontium-89, or other treatments as palliative therapy to lessen bone pain. The objectives of this study is to demonstrate that the use of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) is a safe treatment for recurrent prostate cancer.

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	Verteporfin	In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).
DEVICE	SpectraCure P18 System	Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

Timeline

• Start date: 2017-03-21
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2017-03-01
• Last updated: 2024-12-03

Locations

4 sites across 4 countries: United States, Canada, Sweden, United Kingdom

Regulatory

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