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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Photodynamic Therapy (PDT)
DeviceThe 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.
Verteporfin Injection
DrugVerteporfin for Injection (VFI), photosensitizing drug, will be administered intravenously at a dose of 15 mg/m2 body surface area.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: PDT with VFIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.2
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 PDT3
Treatment efficacy
Percentage of subjects with negative in-field biopsies (histopathologically tumor-free)
Time frame
6 and 18 months post PDTSecondary outcomes
1
Adequacy of effectiveness
Extent of quantifiable treatment effect in the prostate evaluated by MRI to determine the extent of necrosis in the prostate
Time frame
Within 1 week following PDT2
Treatment efficacy
Rate of negative in-field biopsy as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant).
Time frame
6 and 18 months post PDT3
Device performance
Light dose coverage \>90% of the target volume; evaluated by dose-volume histograms in \>80% of subjects
Time frame
Day of PDT4
Percentage of subjects with biochemical failure
Failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir
Time frame
6 and 10 weeks, 6, 18, 24 and 36 months post PDTSponsors and contacts
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Source ClinicalTrials.gov