Study to assess the safety and efficacy of the SpectraCure P18 System

Phase 1

• Conditions: Recurrent prostate cancer; MedDRA version: 21.0Level: PTClassification code: 10036911Term: Prostate cancer recurrent Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502285-24-00
• Lead Sponsor: SpectraCure AB (publ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

Phase 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., Phase 2: 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., Phase 2: Treatment target volume less than 50 cm3., Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Phase 2: Expected survival = 12 months., Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count = 1500/mm3, platelet count = 100,000/mm3., Phase 2: Adequate renal function as defined by creatinine = 1.5 mg /dl., Phase 2: Adequate hepatic function, based on a total bilirubin = 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) = 3 times the upper limit of normal, and alanine transaminase (ALT) = 3 times the upper limit of normal., Phase 2: Signed Informed Consent., Phase 1: Treatment target volume less than 50 cm3 defined by transrectal ultrasound., Phase 1: Subject not eligible for surgery or curative radiotherapy., Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Phase 1: Expected survival = 8 months., Phase 1: Sufficient bone marrow reserve as indicated by; granulocyte count = 1500/mm3, platelet count = 100,000/mm3., Phase 1: Adequate renal function as defined by creatinine = 1.5 mg /dl., Phase 1: Adequate hepatic function, based on a total bilirubin = 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) = 3 times the upper limit of normal, and alanine transaminase (ALT) = 3 times the upper limit of normal., Phase 1: Signed Informed Consent

Exclusion Criteria

Phase 1: Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease., Phase 1: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)., Phase 1: Concomitant infection, Phase 1: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study., Phase 1: 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., Phase 1: Contraindication for photosensitizer, Phase 1: Porphyria or other diseases exacerbated by light., Phase 1: Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions., Phase 2: Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET., Phase 2: Subjects who have been treated with seed implantation brachytherapy, Phase 2: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)., Phase 1: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients., Phase 2: Concomitant infection., Phase 2: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study., Phase 2: 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., Phase 2: Contraindication for photosensitizer., Phase 2: Porphyria or other diseases exacerbated by light., Phase 2: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients, Phase 2: Known allergies to porphyrins., Phase 2: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site., Phase 2: On-going therapy with a photosensitizing agent., Phase 2: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study., Phase 1: Known allergies to porphyrins., Phase 1: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site., Phase 1: On-going therapy with a photosensitizing agent., Phase 1: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study., Phase 1: Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episodes or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation., Phase 1: Patients who have been treated with seed implantation brachytherapy., Phase 1: Gleason score 10 at initial diagnosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified