Recurrent prostate cancer
Conditions
Brief summary
Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT., Phase 1: Performance endpoint for the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Phase 2: Efficacy - Percentage of subjects with negative biopsies (histopathologically tumor-free) 6 months after PDT procedure. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful.
Detailed description
Phase 1: Adequacy of effectiveness will be evaluated by MRI within one week to determine the extent of necrosis in the prostate (>70% of target volume in >50% of subjects)., Phase 2: Efficacy - Percentage of subjects with remaining localized tumour evaluated by MRI 12 months following PDT. Percentage of subjects with biochemical failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir obtained 6 weeks following PDT, confirmed by a second PSA value 4 weeks later. Percentage of subjects with extra prostatic or distant disease evaluated by PSMA PET 12 months following PDT in case of biochemical failure., Phase 2: Performance - The SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Phase 2: Safety - Adverse events will be collected throughout the study. 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.
Interventions
DRUGCIPROFLOXACIN
Sponsors
SpectraCure AB (publ)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT., Phase 1: Performance endpoint for the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Phase 2: Efficacy - Percentage of subjects with negative biopsies (histopathologically tumor-free) 6 months after PDT procedure. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Adequacy of effectiveness will be evaluated by MRI within one week to determine the extent of necrosis in the prostate (>70% of target volume in >50% of subjects)., Phase 2: Efficacy - Percentage of subjects with remaining localized tumour evaluated by MRI 12 months following PDT. Percentage of subjects with biochemical failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir obtained 6 weeks following PDT, confirmed by a second PSA value 4 weeks later. Percentage of subjects with extra prostatic or distant disease evaluated by PSMA PET 12 months following PDT in case of biochemical failure., Phase 2: Performance - The SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects., Phase 2: Safety - Adverse events will be collected throughout the study. | — |
Countries
Germany, Sweden
Outcome results
None listed