Health technology assessment of 177Lu- PSMA-617 treatment for metastatic castration resistant prostate cancer - Protocol for Health technology assessment

Summary

Prostate cancer is the most common cancer type among Norwegian men. In 10-20% of these patients, the cancer will advance to metastatic, castration resistant prostate cancer (mCRPC). As mCRPC is incurable, the treatment options are limited to palliative therapy, using radiation and chemotherapy to manage symptoms and prolong life. Radioligand therapy (RLT) is increasingly being used for treating various malignancies. RLT of mCRPC uses the radionuclide lutetium-177 coupled with a binding ligand for prostate-specific membrane antigen (PSMA).

The Norwegian Institute of Public Health has been commissioned to assess the efficacy and safety of 177Lu-PSMA-617 treatment of prostate cancer, in addition to organisational scenarios and health economic consequences with this treatment, in a full health technology assessment (HTA).We will perform a systematic search for literature in relevant databases. References will be screened for title, abstract and full-text, and included in accordance with predetermined selection criteria. We will extract and analyse data from the included studies, and the results will be compiled and presented in a report written in English. The methodological quality of the included studies will be assessed, as will the certainty of the evidence, i.e., our confidence in the results. We will also perform a health economic evaluation and a five-year budget impact. If we receive a documentation package from Novartis, we will implement this in our work, while still maintaining to perform a full HTA.