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

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 verifiedlocal 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, serumglutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, andalanine transaminase (ALT) ≤ 3 times the upper limit of normal

9. Signed Informed Consent

Phase 1 Exclusion Criteria:

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 accessdevice insertion)

5. Concomitant infection

6. Subjects with other severe concurrent disease that in the judgement of theinvestigator would make the subject inappropriate for entry into this study

7. Mental incapacity or psychiatric illness that would interfere with the subject'sability to understand and give informed consent or to complete follow-up visitsaccording 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 theexcipients

11. Known allergies to porphyrins

12. Tumours known to be eroding into a major blood vessel in or adjacent to theillumination site

13. On-going therapy with a photosensitizing agent

14. Enrolment in another therapeutic clinical study within 3 months prior torandomization and throughout the study.

15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separateepisode or symptoms lasting more than 3 months after initiation of medicalintervention) grade 2 proctitis attributed to radiation.

Phase 2 Inclusion Criteria:

1. Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologicallyverified local recurrence.

2. Treatment target volume less than 50 cm3.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Expected survival ≥ 12 months.

5. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, ≥ 100,000/mm3.

6. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.

7. 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 alaninetransaminase (ALT) ≤ 3 times the upper limit of normal.

8. Signed Informed Consent.

Phase 2 Exclusion Criteria:

1. Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph nodemetastasis, or metastatic disease defined by PSMA PET.

2. Subjects who have been treated with seed implantation brachytherapy.

3. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular accessdevice insertion).

4. Concomitant infection.

5. Subjects with other severe concurrent disease that in the judgement of theinvestigator would make the subject inappropriate for entry into this study.

6. Mental incapacity or psychiatric illness that would interfere with the subject'sability to understand and give informed consent or to complete follow-up visitsaccording to the judgement of the investigator.

7. Contraindication for photosensitizer.

8. Porphyria or other diseases exacerbated by light.

9. Known hypersensitivity to verteporfin for injection (VFI) or to any of theexcipients.

10. Known allergies to porphyrins.

11. Tumours known to be eroding into a major blood vessel in or adjacent to theillumination site.

12. On-going therapy with a photosensitizing agent.

13. Enrolment in another therapeutic clinical study within 3 months prior torandomization and throughout the study.

14. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separateepisode or symptoms lasting more than 3 months after initiation of medicalintervention) grade 2 proctitis attributed to radiation.

15. Contraindication for MRI/Gadolinium contrast such as: implants, severe renalimpairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrastreactions.

16. On-going or planned hormone therapy.