Testing Verteporfin with SpectraCure P18 System for recurrent prostate cancer

Exclusion

• −Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
• −Known allergies to porphyrins
• −Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
• −Known allergies to porphyrins.
• −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
• −Concomitant infection
• −Subjects with other severe concurrent disease that in the judgement of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or to complete follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → visits according to the judgement of the investigator
• −Contraindication for photosensitizer
• −Porphyria or other diseases exacerbated by light
• −Tumours known to be eroding into a major blood vessel in or adjacent to the illumination siteTrial siteA hospital or clinic where a study is actually run.Read more →
• −On-going therapy with a photosensitizing agent
• −EnrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another therapeutic clinical study within 3 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → and throughout the study.
• −Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
• −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 CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −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.
• −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.
• −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.
• −Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2, or previous contrast reactions.
• −Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
• −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.
• −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.
• −Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
• −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.
• −On-going or planned hormone therapy.