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Genital Neoplasms, Male

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Genital Diseases, Male

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Verteporfin

Photosensitizing Agents

Verteporfin and Interstitial Photodynamic Therapy are the interventions in this dose titration study.

The interventions will be light dose (as laser) using the SpectraCure P18 System and drug intervention with verteporfin as a photosensitizer.

The study will be conducted as a dose titration study to determine the light and drug threshold dose using the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI).

The light is delivered to the tumor via optical fibers and each dose arm will receive Interventional Photodynamic Therapy of Prostate Cancer combined with the drug verteporfin as a photosensitizer .

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).

Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

SpectraCure P18 System

Johannes Swartling

James Eastham, MD

Keith Cengel, MD

Sally Mcnulty, RN

Neil Fleshner, MD

Nathan Perlis, MD

Emelie Winell, RN

Anders Bjartell, Prof

Caroline Moore, Prof

Rebecca Scott, RN

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.

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.

As result of the accelerated titration design with light dose and verteporfin for injection (VFI), the final number of subjects depends on the outcome of the titration. If all dose levels enroll and complete at the minimum number of subjects, the number of subjects is 12 (1 each at dose levels 1-3, 3 each at dose levels 4-6). If all dose levels enroll and complete at the maximum number of subjects, the number of subjects is 36 (6 subjects at each dose level 1-6). The range is thus 12-36 subjects for the dose-escalation phase.

25-30 subjects will be treated in an expanded cohort.

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

Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.

Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI.

Performance of the SpectraCure P18 system will be evaluated by light dose-volume histograms for the light dose coverage

Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate

Failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir.

Spots Global Cancer Trial Database for spectracure p18 system