Clinical Study to Assess the Safety and Adequacy of Effectiveness of the SpectraCure P18 System

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 the standard treatment of the
primary disease, include the following:

Radiation therapy.

- Prostatectomy for subjects initially treated with radiation therapy.

- Hormone therapy.

- Pain medication, external radiation therapy, internal radiation therapy with
radioisotopes such as strontium-89, or other treatments as palliative therapy to lessen
bone pain.

The objectives of this study is to demonstrate that the use of the SpectraCure P18 System
(Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI)
is a safe treatment for recurrent prostate cancer.

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 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

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 access
device insertion)

5. Concomitant infection including known human immunodeficiency virus (HIV) 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.