RecruitingPhase 1Phase 2NCT03067051

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


Sponsor

SpectraCure AB

Enrollment

66 participants

Start Date

Mar 21, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new light-based treatment (photodynamic therapy) called the SpectraCure P18 System for men with prostate cancer that has come back after radiation therapy, to assess whether it is safe and effective at destroying the recurring tumor without surgery. **You may be eligible if...** - You are a male over 18 (Phase 1) who has had prior radiation therapy for localized prostate cancer and your cancer has come back, confirmed by biopsy - Your prostate is small enough (under 50 cm³) and the cancer is confined to the prostate (not spread elsewhere) - You are not eligible for repeat surgery or additional radiation therapy - You are in good physical health (ECOG 0 or 1) with adequate blood counts, kidney, and liver function - Your expected survival is at least 8 months (Phase 1) or 12 months (Phase 2) **You may NOT be eligible if...** - Your cancer has spread beyond the prostate (advanced or metastatic disease) - You previously had seed implant brachytherapy - You have an active infection or a serious concurrent illness - You have a light-sensitivity disorder such as porphyria, or allergies to the study's light-activating drug (verteporfin) - You are receiving hormone therapy or another form of photosensitizing treatment - You have a history of severe radiation-related rectal injury 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.

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Interventions

DRUGVerteporfin

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).

DEVICESpectraCure P18 System

Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system


Locations(4)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Skåne University Hospital

Malmö, Skåne County, Sweden

Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust

London, United Kingdom

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NCT03067051


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