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

Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.

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.

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 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

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 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.

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 histopathologically verified 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, platelet count ≥ 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 alanine transaminase (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 node metastasis, 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 access device insertion).
4. Concomitant infection.
5. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
6. 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.
7. Contraindication for photosensitizer.
8. Porphyria or other diseases exacerbated by light.
9. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
10. Known allergies to porphyrins.
11. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
12. On-going therapy with a photosensitizing agent.
13. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
14. 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.
15. Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.
16. On-going or planned hormone therapy.