Title: 177Lu vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more therapies [ID3840]
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 family origin and people with a family history of the condition. [1] In England between April 2018 and April 2019, around 52,580 people were diagnosed with prostate cancer and in 2018 10,068 died from the condition. [3],[4] Around 13% had metastatic disease, that is disease that has spread to other parts of the body (for example, the bones). [4] _x000D_ _x000D_ Prostate cancers can highly express a transmembrane protein called prostatespecific membrane antigen (PSMA). PSMA expression is further increased in poorly differentiated, metastatic, and hormone-refractory prostate cancers. [5]_x000D_ _x000D_ NICE clinical guideline 131 recommends androgen deprivation therapy (luteinising hormone-releasing hormone agonist therapy, bicalutamide or bilateral orchidectomy) for people whose prostate cancer is sensitive to such hormonal therapy. Docetaxel can be added to luteinising hormone-releasing hormone agonist therapy. Enzalutamide with androgen deprivation therapy is recommended for treating hormone-sensitive metastatic prostate cancer (TA712). Apalutamide with androgen deprivation therapy is recommended for treating hormone-sensitive metastatic prostate cancer (TA741)._x000D_ _x000D_ Hormone-relapsed prostate cancer (also known as hormone-resistant, hormonerefractory and castration-resistant) refers to prostate cancer which has progressed on androgen deprivation therapy. Darolutamide with androgen deprivation therapy is recommended for treating hormone-relapsed non-metastatic prostate cancer (TA660). Apalutamide with androgen deprivation therapy is recommended for treating high-risk hormone-relapsed non-metastatic prostate cancer (TA740). Similarly, enzalutamide is recommended for treating high-risk hormone-relapsed nonmetastatic prostate cancer (TA580). Abiraterone in combination with prednisone or prednisolone is recommended for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (TA387). Similarly, enzalutamide is recommended for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (TA377)._x000D_ _x000D_ NICE guideline 131 and TA101 recommends chemotherapy (docetaxel) as a treatment option for people with metastatic hormone-relapsed prostate cancer if their Karnofsky performance-status score is 60% or more._x000D_ _x000D_ Abiraterone in combination with prednisone or prednisolone and enzalutamide are also recommended for metastatic hormone-relapsed prostate cancer if it has progressed on a docetaxel-containing chemotherapy regimen (TA259 and TA317 respectively). _x000D_ _x000D_ Radium 223 dichloride is recommended for treating hormone-relapsed prostate cancer with bone metastases in people who already had a docetaxel, or for whom docetaxel is contraindicated or unsuitable (TA412)._x000D_ _x000D_ Cabazitaxel in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone-relapsed prostate cancer in people whose disease has progressed during or after docetaxel therapy (TA391). _x000D_ _x000D_ References_x000D_ 1. Cancer Research UK (2020) Prostate cancer risks and causes. Accessed April 2021._x000D_ 2. Macmillan Cancer Support (2018) Potential causes of prostate cancer. Accessed May 2021._x000D_ 3. Cancer Research UK (2018) Prostate cancer mortality statistics. Accessed April 2021._x000D_ 4. National Prostate Cancer Audit (2021) Annual Report 2020. Accessed May 2021_x000D_ 5. Bouchelouche K, Choyke PL, Capala J. Prostate specific membrane antigen- a target for imaging and therapy with radionuclides. Discov Med.2010 Jan;9(44):55-61.

Lay abstract: To appraise the clinical and cost effectiveness of 177Lu-PSMA-617 within its marketing authorisation for treating previously treated prostate-specific membrane antigen (PSMA) positive, hormone-relapsed metastatic prostate cancer.

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