Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
ConditionRecurrent Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSpectraCure AB
About this trial
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.
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
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
Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
Trial design
Treatments tested in this trial
- Verteporfin
- SpectraCure P18 System
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov