Primary localised prostate cancer
Conditions
Brief summary
Safety: Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events.
Detailed description
Device performance: Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Adequacy of effectiveness: Extent of quantifiable treatment effect in the prostate evaluated by MRI one-week post-PDT by calculating the percentage of necrosis evaluated by MRI. Descriptive statistics will be presented for each subject., Efficacy: Percentage of subjects with negative in-field biopsies (histopathologically tumour free) at 6 months. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful. The rate of negative in-field biopsy at 6 and 18 months as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant).
Interventions
DRUGCIPROFLOXACIN
Sponsors
SpectraCure AB (publ)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Device performance: Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Adequacy of effectiveness: Extent of quantifiable treatment effect in the prostate evaluated by MRI one-week post-PDT by calculating the percentage of necrosis evaluated by MRI. Descriptive statistics will be presented for each subject., Efficacy: Percentage of subjects with negative in-field biopsies (histopathologically tumour free) at 6 months. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful. The rate of negative in-field biopsy at 6 and 18 months as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant). | — |
Countries
Germany
Outcome results
None listed