SpectraCure AB
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…
Phase 1 Inclusion Criteria: 1. Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence. 2. Prostate volume less than 50 cm3 defined by transrectal ultrasound 3. Subject not eligible for surgery or curative radiotherapy 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Expected survival ≥ 8 months 6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3 7. Adequate renal function as defin…
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
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