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

A regiszterben nem jelölt feltételek

• Phase 1 Inclusion Criteria:
• 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.
• Prostate volume less than 50 cm3 defined by transrectal ultrasound
• Subject not eligible for surgery or curative radiotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Expected survival ≥ 8 months
• Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
• Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
• 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
• Signed Informed Consent
  • Phase 1 Exclusion Criteria:
• 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.
  • Phase 2 Inclusion Criteria:
• 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.
• Treatment target volume less than 50 cm3.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival ≥ 12 months.
• Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
• Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
• 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.
• Signed Informed Consent.
  • Phase 2 Exclusion Criteria:
• 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.