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
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.
• Subjects ≥ 18 years.
• 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.
• 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.
• Gleason Score 7 (3+4 or 4+3).
• PSA ≤ 15 ng/mL.
• Lesion volume on mpMRI \< 1.5 cm3.
• Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer.
• \- Bone scan is optional if PSA \< 10 ng/mL.
• Treatment target volume \<50 cm3 defined by TRUS or MRI.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival ≥ 36 months.
⁃ Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
⁃ Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
⁃ Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
⁃ Signed Informed Consent.