Study to Test the Safety and Effectiveness of the SpectraCure P18 System for Recurrent Prostate Cancer

Sponsor: SpectraCure AB

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03067051

Provider View

This clinical trial is evaluating a new treatment system called the SpectraCure P18, which uses a special light-activated drug to treat prostate cancer that has returned after initial treatment. The study aims to determine if this approach is safe and effective.

Patient Parameters

Program Overview

The purpose of this study is to gather information on the safety and effectiveness of the SpectraCure P18 System, which uses a light-sensitive drug called verteporfin, to treat prostate cancer that has come back after initial treatment. The study will also help determine the right dose to use for this treatment.

Description

Prostate cancer is one of the most common cancers among men, with over 200,000 cases diagnosed in North America in 2011 alone. After initial treatment, many men experience a return of their cancer, known as recurrent prostate cancer. Treatment options for recurrent cancer are often more limited and depend on the treatments previously received.

Common treatments for recurrent prostate cancer may include:

  • Radiation therapy
  • Surgery (prostatectomy) for those initially treated with radiation
  • Hormone therapy
  • Pain management and other therapies to relieve symptoms

This study aims to show that the SpectraCure P18 System, which uses multiple diode lasers and special software, along with the drug verteporfin, is a safe option for treating recurrent prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Men over 18 years old who have had radiation therapy for localized prostate cancer and have a confirmed local recurrence.
  • Prostate size less than 50 cm3 as measured by ultrasound.
  • Not eligible for surgery or further radiation therapy.
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live at least 8 months.
  • Adequate bone marrow, kidney, and liver function as shown by specific blood tests.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Advanced or metastatic prostate cancer.
  • Previous treatment with seed implantation brachytherapy.
  • High Gleason score (8 or above) at initial diagnosis.
  • Recent surgery (within the last week), except for minor procedures.
  • Current infections.
  • Other severe health conditions that make participation inappropriate.
  • Mental health issues affecting understanding or consent.
  • Allergies to the study drug or similar substances.
  • Conditions worsened by light exposure.
  • Tumors near major blood vessels.
  • Participation in another clinical study within the last 3 months.
  • Ongoing or planned hormone therapy.

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