[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SpectraCure AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100578135","phase-1-photodynamic-therapy-of-primary-localized-prostate-cancer-with-the-spectracure-p18-system-100578135",false,"NCT06807359","Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System","Open-label Clinical Phase 1\u002F2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer","Inclusion Criteria:\n\n1. Subjects ≥ 18 years.\n2. Histologically confirmed organ-confined adenocarcinoma of the prostate cancer diagnosed within the last 9 months. Including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months.\n\n   a. This prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon.\n3. Gleason Score 7 (3+4 or 4+3).\n4. PSA ≤ 15 ng\u002FmL.\n5. Lesion volume on mpMRI \\\u003C 1.5 cm3.\n6. Adequate stage imaging such as pelvic CT\u002FMRI\u002FPET scan within the last 6 months confirming localized cancer.\n\n   \\- Bone scan is optional if PSA \\\u003C 10 ng\u002FmL.\n7. Treatment target volume \\\u003C50 cm3 defined by TRUS or MRI.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Expected survival ≥ 36 months.\n10. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500\u002Fmm3, platelet count ≥ 100,000\u002Fmm3.\n11. Adequate renal function as defined by creatinine ≤ 1.5 mg \u002Fdl.\n12. 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.\n13. Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.\n2. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI\n3. Contralateral PIRADS 4\u002F5 lesion (even if negative targeted biopsy)\n4. High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as \\>1 core of GG1 with a linear amount of carcinoma \\>6mm.\n5. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.\n6. Prior treatment with any form of brachytherapy.\n7. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.\n8. Prior or current bleeding diathesis.\n9. Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site.\n10. Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.\n11. Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).\n12. 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.\n13. Contraindication for photosensitizer including:\n\n    1. Porphyria or other diseases exacerbated by light.\n    2. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.\n    3. Known allergies to porphyrins.\n14. On-going therapy with a photosensitizing agent.\n15. Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.\n16. Contraindication for MRI\u002FGadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate \\[GFR\\] \\\u003C30 mL\u002Fmin\u002F1.73m2), or previous contrast reactions.\n17. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium","MALE","18 Years",{"count":19,"type":20},43,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, together with verteporfin for injection (VFI) as photosensitizer, for the treatment of primary localized prostate cancer.\n\nThe study will be divided into two parts, with Phase I, dose-escalation, to study safety and establish an effective light dose, followed by Phase II, cohort expansion, to evaluate clinical efficacy and confirm safety\u002Ftolerability. The subjects will be followed for a period of 18 months to determine the primary outcome. The long-term follow-up is an additional 18 months, i.e. a total of 36 months.\n\nInterstitial Photodynamic Therapy (PDT) will be performed during general anesthesia. Optical fibers will be inserted into the prostate with a transperineal approach using transrectal ultrasound guidance. The intent is to deliver an adequate light dose throughout the prostate. Subjects will receive VFI intravenously, approximately 60-90 minutes prior to light delivery.",[27],"Prostate Cancer","RECRUITING","2026-04-30",{"date":31,"type":32},"2026-05-01","ACTUAL",{"date":34,"type":32},"2025-01-06",{"date":36,"type":20},"2029-01",{"name":38,"class":39},"SpectraCure AB","INDUSTRY",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100290921","phase-1-clinical-study-to-assess-the-safety-and-efficacy-of-the-spectracure-p18-system-100290921","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.",{"count":49,"type":20},66,[23,24],"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.",[53],"Recurrent Prostate Cancer","2026-04-27",{"date":31,"type":32},{"date":57,"type":32},"2017-03-21",{"date":59,"type":20},"2027-12-31",{"name":38,"class":39},4,""]