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Expert group comments on results of ongoing study
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
SpectraCure AB (publ) is conducting a clinical study for patients with recurrence of prostate cancer after radiotherapy. The study's expert group, the Data Safety Monitoring Board ("DSMB"), has been able to state that the current treatment is safe with mild to moderate side effects. Magnetic resonance images indicate that treatment has positive effects as it is possible to see areas of necrosis, i.e. cell death. Furthermore, the DSMB has been able to establish that SpectraCure's medical system Q-PRO® delivers the desired dose of light to selected tumour areas in the prostate.
SpectraCure has presented to the DSMB data on patient safety and treatment effects from treatments completed so far in the clinical study of patients with recurrence of prostate cancer after previous radiotherapy. The DSMB is an expert group, consisting of two medical experts and a statistician, responsible for carefully reviewing and evaluating the collected study data with a focus on safety aspects, study implementation and progress. The group is also required to make recommendations regarding how the study should proceed, any adjustments that should be made, or whether it is appropriate to terminate the study.
The expert group has established the following results so far in the study:
- The study is considered safe as the majority of side effects are mild to moderate with a side effect profile expected for this type of treatment.
- Magnetic resonance images indicate positive effects after treatment as it is possible to see areas of necrosis, i.e. cell death.
- The proprietary medical technology system Q-PRO® shows expected performance and delivers the desired light dose to selected tumour areas in the prostate.
The ongoing study for prostate cancer recurrence is strategically important to the planned study for primary localised prostate cancer, which was announced in November and is scheduled to start in the first half of 2024. By starting the larger study, SpectraCure broadens the recruitment base and addresses a larger market.