Open-label Clinical Phase 1/2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer
Summary
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. The 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/tolerability. 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. Interstitial 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.
Arms & interventions
- DevicePhotodynamic Therapy (PDT)
The PDT treatment is provided with the SpectraCure P18 laser light delivery system. 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. The photosensitizer is activated with light of a specific wavelength that is delivered to the tumor via optical fibers. The activated photosensitizer reacts with oxygen to form highly toxic radicals which induce cell death in the tumour. * Phase 1: Light dose escalation. Three subjects will be treated per dose level (20 - 40 J/cm2). If no dose-limiting toxicities occur, dose will be escalated (20 - 40 J/cm2) until the Recommended Phase 2 Dose (RPD2) is established. * Phase 2: Cohort expansion with the RPD2.
- DrugVerteporfin Injection
Verteporfin for Injection (VFI), photosensitizing drug, will be administered intravenously at a dose of 15 mg/m2 body surface area.
Outcome measures
Primary
Safety of treatment
Number of participants with treatment related adverse events as assessed by CTCAE v5.0 related to therapy per protocol. Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.
Time frame: Within 4 weeks of treatment in each cohort.
Safety - Damage to the periprostatic tissue mediated by PDT
Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI.
Time frame: 5-9 days following PDT
Treatment efficacy
Percentage of subjects with negative in-field biopsies (histopathologically tumor-free)
Time frame: 6 and 18 months post PDT
Secondary
Adequacy of effectiveness
Time frame: Within 1 week following PDT
Treatment efficacy
Time frame: 6 and 18 months post PDT
Device performance
Time frame: Day of PDT
Percentage of subjects with biochemical failure
Time frame: 6 and 10 weeks, 6, 18, 24 and 36 months post PDT
Percentage of subjects with extra prostatic or distant disease
Time frame: 6 and 18 months post PDT
Eligibility criteria
Study locations (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065