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

Exclusion Criteria31

• Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
• Patients who have been treated with seed implantation brachytherapy
• Gleason score ≥ 8 at initial diagnosis
• Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
• Concomitant infection
• Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
• 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
• Contraindication for photosensitizer
• Porphyria or other diseases exacerbated by light
• Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
• Known allergies to porphyrins
• Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
• On-going therapy with a photosensitizing agent
• Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• 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.
• Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
• Subjects who have been treated with seed implantation brachytherapy.
• Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
• Concomitant infection.
• Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
• 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.
• Contraindication for photosensitizer.
• Porphyria or other diseases exacerbated by light.
• Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
• Known allergies to porphyrins.
• Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
• On-going therapy with a photosensitizing agent.
• Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• 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.
• Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2, or previous contrast reactions.
• On-going or planned hormone therapy.