The START-NET project: Two complementary, randomized multicenter clinical trials on personalized radionuclide therapy for neuroendocrine tumors

Radionuclide therapy (RNT) is the use of radioactive drugs to treat cancer - a radioactive isotope coupled to a molecule that binds to a target on the tumor cells results in internal, targeted radiotherapy.

RNT can be optimized on an individual level by increasing the dose to the tumors while maintaining a safe dose to normal organs. RNT of neuroendocrine tumors (NETs) is based on targeting of the somatostatin receptors. The approved drug uses a fixed dosing with no personalization.

Three sites in Sweden – Lund, Uppsala and Göteborg – have over a decade of experience from two phase II academic clinical trials exploring safety and efficacy of dosimetry-based RNT in NET.

Together with other sites in the Nordic region, we are now setting up the START-NET project consisting of two Nordic, multicenter clinical trials that will 1) compare personalized, dosimetry-based RNT with or without radiosensitizing chemotherapy, with the currently approved, one-size-fits-all regimen and, 2) explore ways to further sharpen personalized, dosimetry-based RNT.

A parallel translational study coupled to the two clinical trials will deepen our understanding of the molecular mechanisms behind treatment effect and failure.

If the advantage of dosimetry-based RNT can be proven in this indication, it can be easily applied to RNTs currently being developed for prostate, breast, gastrointestinal and other cancers.