Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

Eligibility 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 defined by creatinine ≤ 1.5 mg /dl
• 8. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal
• 9. Signed Informed Consent
• 1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
• 2. Patients who have been treated with seed implantation brachytherapy
• 3. Gleason score ≥ 8 at initial diagnosis
• 4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
• 5. Concomitant infection
• 6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
• 7. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator
• 8. Contraindication for photosensitizer
• 9. Porphyria or other diseases exacerbated by light
• 10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
• 11. Known allergies to porphyrins
• 12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
• 13. On-going therapy with a photosensitizing agent
• 14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• 15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.