Title: Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer [ID3971]
Funder: Department of Health and Social Care

Abstract: Prostate cancer is a condition in which tumours develop in the prostate, a gland in the male reproductive system. The exact cause is unknown but environmental and genetic factors are associated with an increased risk of developing prostate cancer. [1],[2] _x000D_ _x000D_ The incidence of prostate cancer increases with age and is higher in people of black African-Caribbean family origin and people with a family history of the condition.[1] In England, between 2019 and 2020, 43,330 people were diagnosed with prostate cancer. Of those, 13% of people diagnosed had metastatic disease, that is, disease that has spread to other parts of the body (for example, the bones).[3] The age standardised mortality rate for prostate cancer in 2019 was 45.5 for every 100,000 persons.[4] _x000D_ _x000D_ NICE clinical guideline 131 (NG131) classifies localised prostate cancer to be at low, intermediate or high risk of progression based on prostate-specific antigen concentration, Gleason score (based on a biopsy) and clinical stage. People with intermediate or high risk non-metastatic prostate cancer may be offered hormone therapy (also called androgen deprivation therapy). Prostate cancer may initially respond to hormone therapy but eventually become resistant to it. This clinical condition is described as ‘hormone-relapsed’ prostate cancer. _x000D_ _x000D_ For newly diagnosed metastatic prostate cancer, NG131 recommends starting docetaxel chemotherapy within 12 weeks of starting androgen deprivation therapy. For metastatic prostate cancer, the guideline recommends offering bilateral orchidectomy as an alternative to continuous luteinising hormone-releasing hormone agonist therapy. For people who are willing to accept the adverse impact on overall survival and gynaecomastia (breast swelling) in the hope of retaining sexual function, the guideline recommends offering anti-androgen monotherapy with bicalutamide. NICE technology appraisal 404 recommends degarelix, a gonadotrophin-releasing hormone antagonist, for treating advanced hormone-dependent (hormone-sensitive) prostate cancer in people with spinal metastases. In addition, NICE technology appraisal 712 recommends enzalutamide plus androgen deprivation therapy as an option for treating hormone-sensitive metastatic prostate cancer in adults, and NICE technology appraisal 741 recommends apalutamide plus androgen deprivation therapy as an option for treating hormone-sensitive metastatic prostate cancer in adults, if docetaxel is not suitable. _x000D_ _x000D_ The description ‘hormone-sensitive metastatic prostate cancer’ refers to a population that includes people with metastatic prostate cancer who have not had androgen deprivation therapy, or whose disease is continuing to respond to androgen deprivation therapy._x000D_ _x000D_ References_x000D_ 1. Cancer Research UK (2022) Prostate cancer risks and causes. Accessed April 2022._x000D_ 2. Macmillan Cancer Support (2022) Potential causes of prostate cancer. Accessed April 2022._x000D_ 3. National Prostate Cancer Audit (2021) Annual report 2021. Accessed April 2022._x000D_ 4. NHS Digital (2022). Cancer registration statistics, England 2019. Accessed April 2022

Lay abstract: To appraise the clinical and cost effectiveness of darolutamide with androgen deprivation therapy and docetaxel within its marketing authorisation for treating hormone-sensitive metastatic prostate cancer.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS