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

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.

Trial Details

NCT ID
NCT03067051
Phase
PHASE1 / PHASE2
Sponsor
SpectraCure AB
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Verteporfin
  • SpectraCure P18 System
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597
  • Toronto, Ontario, Canada|43.65333,-79.38389
  • Malmö, Skåne County, Sweden|55.60587,13.00073
  • London, United Kingdom|51.50853,-0.12574

Key Eligibility Criteria

  • Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopat…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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