Clinical study

The completed phase 1 study for the treatment of patients with recurrence of prostate cancer after radiation therapy aimed to determine the method as user-safe and the correct dose of drug and laser light.

In the study, the dose of drug and laser light was gradually increased until the correct total dose was reached. After the treatment, each patient is followed up for 12 months, including magnetic camera examinations (MRI) after 1 week and 12 months, regular blood tests, and biopsy after 12 months.

Phase 2 study

The study protocol, the drug and SpectraCure’s IDOSE-system have been approved for clinical trials by the US FDA and the Canadian Medicines Agency Health Canada. The approved study protocol indicated that a continued phase 2 study could be started 28 days after the last patient treatment in phase 1.

During SpectraCure’s ongoing clinical trial, the American FDA (Food and Drug Administration) has created an opening for faster product launch by changing the requirements for endpoints in clinical trials in cancer treatment. An of FDA approved accelerated approval which may admit shorter follow-up time, could in turn, be supplemented with requirements for reporting follow-up studies after approval.

Phase 3 study

To obtain approval from the authorities to sell the product to the healthcare system, the company must rigorously demonstrate that the method is safe to use and gives the intended clinical effect. This is done in a phase 3 clinical study, which will include a larger patient base than the phase 1 and phase 2 studies. The Phase 3 study will therefore be carried out in more hospitals. SpectraCure may launch the treatment system sooner after an approval according to accelerated approval by the FDA, provided the results at the time of launch are good. The phase 3 study, with treatment and follow-up studies, will proceed as planned.