Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System

Official Title

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

Summary:

The rationale for the study is to obtain safety 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.

Trial Description

Primary Outcome:

• Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.

Secondary Outcome:

• Damage to the periprostatic tissues including the rectal wall mediated by PDT
• Performance of SpectraCure P18 system
• Adequacy of effectiveness

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 tumours 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.

View this trial on ClinicalTrials.gov