Observational Study (Registry) on the Treatment of Urological Cancers with Systemic Therapies in Everyday Clinical Practice

The term “urological cancers” refers to malignant tumors of the urinary tract and the male reproductive organs. These include cancers of the prostate, the testicles, and the penis, as well as the kidney, the renal pelvis, the ureter, and the bladder. Women can also be affected by cancers that involve the urinary organs. In malignant tumors, the body’s own cells multiply uncontrollably. The tumor cells can invade surrounding tissue, spread through the bloodstream and lymphatic system, and form secondary tumors (metastases) in other parts of the body. The urothelium is the multilayered epithelial tissue that lines, among other structures, the renal pelvis, ureter, and bladder. Malignant tumors that originate in this tissue are referred to as urothelial carcinoma. Systemic therapies are medications that are distributed throughout the body via the bloodstream and can thus exert their effects there as well. These include, for example, chemotherapy, immunotherapy, targeted therapies, and anti-hormone therapy. Chemotherapy consists of cell-damaging agents that interfere with cell division, thereby primarily damaging rapidly dividing cells such as cancer cells, although healthy cells may also be affected. Immunotherapy is designed to help the body’s own immune system recognize and fight cancer cells. Targeted therapies interfere with specific proteins or signaling pathways involved in the growth of cancer cells. Targeted cancer drugs also include antibody-drug conjugates, which combine an antibody—that binds to a surface marker found primarily on cancer cells—with a cytotoxic agent. This combination is delivered specifically to the cancer cells, where the cytotoxic agent is released. The growth of prostate cancer cells can be driven by male sex hormones (androgens, primarily testosterone). Hormone therapy is designed to reduce the effect of these sex hormones in the body and thereby slow the growth of cancer cells.

The goal of this GUARDIANS registry study is to investigate the use, efficacy, and tolerability of these systemic therapies under real-world conditions. This is a non-interventional, retrospective registry study. Treatment is based exclusively on routine clinical decisions; this means that the treating physician decides on a specific therapy independently of the study. No additional study-related examinations or treatments are performed. The study evaluates previously documented treatment courses, with data collected anonymously. All patients are grouped together in a single observation group; there is no comparison group. The main objective (primary endpoint) of the study is to measure the time from the start of therapy until disease progression or death (progression-free survival, PFS). Additional objectives include recording the duration of therapy and dose adjustments over the course of treatment, as well as the reasons for discontinuing therapy or any side effects that occur.

Eligible participants are patients aged 18 years or older with a confirmed diagnosis of urological cancer (prostate, bladder, ureter, kidney, renal pelvis, penile, or testicular cancer) who are receiving systemic therapy and are being treated and documented at a participating center in a German-speaking country. Treatment courses with incomplete or contradictory documentation will not be included.