Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSpectraCure AB
About this trial
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.
Eligibility criteria
Qualifiers
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.
Gleason Score 7 (3+4 or 4+3).
PSA ≤ 15 ng/mL.
Disqualifiers
Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.
Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI
Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)
High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as >1 core of GG1 with a linear amount of carcinoma >6mm.
Trial design
Treatments tested in this trial
- Photodynamic Therapy (PDT)
- Verteporfin Injection
Treatment groups
43 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov