Long-Term Follow-Up Study on the Treatment of Recurrent and Metastatic Prostate Cancer (PROCARE)

Prostate cancer is one of the most common types of cancer in men. After local treatment such as surgery or radiation therapy, the cancer may recur, which is often first detected by an increase in the PSA level in the blood (biochemical recurrence). If this cancer cannot be controlled despite local treatment and possibly additional measures, systemic treatment is usually required. This initially involves lowering testosterone levels (anti-hormone therapy). Since testosterone is necessary for the growth of prostate cancer cells, the goal is to slow their growth. In some cases, the cancer continues to progress even though testosterone levels are being lowered by medication; this is referred to as castration-resistant prostate cancer, or the cancer spreads to other organs (metastasizes). Depending on the stage and course of the disease, there are then various treatment options.

The PROCARE study is what is known as a registry study. This means that no new drugs are being tested; instead, the therapies used in routine clinical practice and their outcomes are being documented. The goal is to obtain an accurate picture of which treatments are used in Germany under real-world conditions, how effective they are, and how well they are tolerated. Patients are divided into four groups (cohorts): 1. Patients with a recurrence of elevated PSA levels following local treatment (biochemical recurrence) 2. Patients with castration-resistant prostate cancer that has not yet metastasized 3. Patients with metastatic prostate cancer that has not yet been treated with hormone therapy (hormone-sensitive) 4. Patients with metastatic castration-resistant prostate cancer (does not respond to hormone therapy) As part of the study, data on disease progression, treatments received, and side effects are regularly collected. In addition, patients will complete questionnaires about their quality of life. Blood samples may also be collected to investigate possible associations between certain biological characteristics (biomarkers) and the course of the disease. The follow-up period lasts up to seven years.

Men aged 18 and older who have recurrent or metastatic prostate cancer and are starting a new course of drug therapy or are about to start one (up to 4 weeks after initiation) are eligible to participate. Participation is not possible if there are severe comorbidities that would make follow-up difficult.