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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Verteporfin
DrugIn the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).
SpectraCure P18 System
DeviceInterstitial Photodynamic therapy is provided with the the SpectraCure P18 system
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: PDT and verteporfin dose findingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
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
Percentage of subjects with negative biopsies.
Histopathologically tumor-free.
Time frame
6 months following PDT.Secondary outcomes
1
Damage to the periprostatic tissues including the rectal wall 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 PDT2
Performance of SpectraCure P18 system
Performance of the SpectraCure P18 system will be evaluated by light dose-volume histograms for the light dose coverage
Time frame
Dose-volume histograms will be evaluated at month 123
Adequacy of effectiveness
Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate
Time frame
Within 1 week of treatment4
Percentage of subjects with remaining localized tumour.
Evaluated by MRI.
Time frame
12 months following PDT.Sponsors and contacts
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Source ClinicalTrials.gov