Study to assess the safety and efficacy of the SpectraCure P18 System

Prior treatment

• Phase 1: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
• Phase 1: Concomitant infection
• Phase 1: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
• Phase 2: Subjects who have been treated with seed implantation brachytherapy
• Phase 2: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
• Phase 2: Concomitant infection.
• Phase 2: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
• Phase 2: On-going therapy with a photosensitizing agent.
• Phase 2: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• Phase 1: On-going therapy with a photosensitizing agent.
• Phase 1: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• Phase 1: Patients who have been treated with seed implantation brachytherapy.

Other illness

• Phase 1: Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease.
• Phase 1: 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.
• Phase 1: Porphyria or other diseases exacerbated by light.
• Phase 2: Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
• Phase 1: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
• Phase 2: 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.
• Phase 2: Porphyria or other diseases exacerbated by light.
• Phase 2: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
• Phase 2: Known allergies to porphyrins.
• Phase 1: Known allergies to porphyrins.
• Phase 1: Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episodes or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.

Lab values

• Phase 1: Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.

Other

• Phase 1: Contraindication for photosensitizer
• Phase 2: Contraindication for photosensitizer.
• Phase 2: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
• Phase 1: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
• Phase 1: Gleason score 10 at initial diagnosis.

• Phase 1: Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
• Phase 2: Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
• Phase 2: Treatment target volume less than 50 cm3.
• Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Phase 2: Expected survival ≥ 12 months.
• Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
• Phase 2: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
• Phase 2: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
• Phase 2: Signed Informed Consent.
• Phase 1: Treatment target volume less than 50 cm3 defined by transrectal ultrasound.
• Phase 1: Subject not eligible for surgery or curative radiotherapy.
• Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Phase 1: Expected survival ≥ 8 months.
• Phase 1: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
• Phase 1: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
• Phase 1: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
• Phase 1: Signed Informed Consent