[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100290921":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":104,"collaborators":28,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":28,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":28,"enrollmentInfo":115,"targetDuration":28,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"SpectraCure AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PDT and verteporfin dose finding","EXPERIMENTAL","Verteporfin and Interstitial Photodynamic Therapy are the interventions in this dose titration study.\n\nThe interventions will be light dose (as laser) using the SpectraCure P18 System and drug intervention with verteporfin as a photosensitizer.\n\nThe study will be conducted as a dose titration study to determine the light and drug threshold dose using the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI).\n\nThe light is delivered to the tumor via optical fibers and each dose arm will receive Interventional Photodynamic Therapy of Prostate Cancer combined with the drug verteporfin as a photosensitizer .",[13,14],"Drug: Verteporfin","Device: SpectraCure P18 System",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Verteporfin","In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).",[9],[22],"Visudyne",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","SpectraCure P18 System","Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system",[9],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Johannes Swartling","CONTACT","+46 (0) 46 16 20 70","jsw@spectracure.com",[36,52,71,88],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Memorial Sloan Kettering Cancer Center","RECRUITING","New York","10065","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":28,"phoneExt":28,"email":28},"James Eastham, MD",{"facility":53,"status":38,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Princess Margaret Cancer Centre","Toronto","Ontario","ON M5G 2M9","Canada","CA",{"type":44,"coordinates":60},[61,62],-79.39864,43.70643,{"lat":62,"lon":61},[65,67],{"name":66,"role":32,"phone":28,"phoneExt":28,"email":28},"Neil Fleshner, MD",{"name":68,"role":32,"phone":69,"phoneExt":70,"email":28},"Nathan Perlis, MD","416-946-4501","3381",{"facility":72,"status":38,"city":73,"state":74,"zip":28,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Skåne University Hospital","Malmö","Skåne County","Sweden","SE",{"type":44,"coordinates":78},[79,80],13.00073,55.60587,{"lat":80,"lon":79},[83,85],{"name":84,"role":32,"phone":28,"phoneExt":28,"email":28},"Emelie Winell, RN",{"name":86,"role":87,"phone":28,"phoneExt":28,"email":28},"Anders Bjartell, Prof","PRINCIPAL_INVESTIGATOR",{"facility":89,"status":38,"city":90,"state":28,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust","London","W1W 7TS","United Kingdom","UK",{"type":44,"coordinates":95},[96,97],-0.12574,51.50853,{"lat":97,"lon":96},[100,102],{"name":101,"role":32,"phone":28,"phoneExt":28,"email":28},"Caroline Moore, Prof",{"name":103,"role":32,"phone":28,"phoneExt":28,"email":28},"Rebecca Scott, RN",{"type":105,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100290921","phase-1-clinical-study-to-assess-the-safety-and-efficacy-of-the-spectracure-p18-system-100290921",false,"NCT03067051","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","Phase 1 Inclusion Criteria:\n\n1. 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.\n2. Prostate volume less than 50 cm3 defined by transrectal ultrasound\n3. Subject not eligible for surgery or curative radiotherapy\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Expected survival ≥ 8 months\n6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500\u002Fmm3, platelet count ≥ 100,000\u002Fmm3\n7. Adequate renal function as defined by creatinine ≤ 1.5 mg \u002Fdl\n8. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg\u002Fdl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal\n9. Signed Informed Consent\n\nPhase 1 Exclusion Criteria:\n\n1. Patients with locally advanced (AJCC 7th edition T3\u002FT4) or metastatic disease\n2. Patients who have been treated with seed implantation brachytherapy\n3. Gleason score ≥ 8 at initial diagnosis\n4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)\n5. Concomitant infection\n6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study\n7. 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\n8. Contraindication for photosensitizer\n9. Porphyria or other diseases exacerbated by light\n10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients\n11. Known allergies to porphyrins\n12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site\n13. On-going therapy with a photosensitizing agent\n14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.\n15. 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.\n\nPhase 2 Inclusion Criteria:\n\n1. 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.\n2. Treatment target volume less than 50 cm3.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Expected survival ≥ 12 months.\n5. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500\u002Fmm3, platelet count ≥ 100,000\u002Fmm3.\n6. Adequate renal function as defined by creatinine ≤ 1.5 mg \u002Fdl.\n7. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg\u002Fdl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.\n8. Signed Informed Consent.\n\nPhase 2 Exclusion Criteria:\n\n1. Subjects with locally advanced (AJCC 7th edition T3\u002FT4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.\n2. Subjects who have been treated with seed implantation brachytherapy.\n3. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).\n4. Concomitant infection.\n5. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.\n6. 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.\n7. Contraindication for photosensitizer.\n8. Porphyria or other diseases exacerbated by light.\n9. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.\n10. Known allergies to porphyrins.\n11. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.\n12. On-going therapy with a photosensitizing agent.\n13. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.\n14. 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.\n15. Contraindication for MRI\u002FGadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \\[GFR\\] \\\u003C30 mL\u002Fmin\u002F1.73m2, or previous contrast reactions.\n16. On-going or planned hormone therapy.","MALE","18 Years",{"count":116,"type":117},66,"ESTIMATED","INTERVENTIONAL",[120,121],"PHASE1","PHASE2","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.",[124],"Recurrent Prostate Cancer","2026-04-27",{"date":127,"type":128},"2026-05-01","ACTUAL",{"date":130,"type":128},"2017-03-21",{"date":132,"type":117},"2027-12-31",{"name":5,"class":6},4]