Improving the impact of anti-androgen treatments on patients' daily lives and their cancer (DE-ESCALATE)

There is a type of prostate cancer that responds to male hormones: testosterone and other androgens are produced by the body. These hormones promote cancer growth. Current cancer treatment aims to inhibit the production and effect of these hormones. For this reason, patients are given two drugs. One prevents the production of testosterone in the body, the other blocks the effect of androgens on the cancer cells. This combination therapy is known as maximum androgen blockade. In current practice, it is continued without interruption until the disease progresses. However, long-term continuous use of androgen blockade can affect quality of life and cause hot flushes, fatigue and a reduction or loss of sexual function. Recent studies have shown that this treatment can be interrupted until the prostate-specific antigen (PSA) level rises again. This so-called intermittent therapy is associated with fewer side effects - without affecting the survival rate. The aim of this study is therefore to show whether the combination of the two drugs in maximum androgen blockade can be reduced - and whether this can improve the risk-benefit ratio of the treatment.

Intervention studied

Comparison between continuous treatment and intermittent treatment: It is discontinued as long as the PSA value is 0.2 ng/ml or less and is resumed when the value exceeds this low threshold.

Questionnaires are used to find out how the patients feel.

Criteria for participation
Patients with metastatic prostate cancer who have already been treated with maximum androgen blockade for 6 to 12 months and have a PSA value of 0.2 ng/ml or less.

Exclusion criteria
Patients with metastatic prostate cancer in the M1a stage for whom radiotherapy and 2 to 3 years of hormone therapy are planned Patients who have undergone or will undergo bilateral orchiectomy, i.e. removal of both testicles Patients who have previously or simultaneously been affected by another type of cancer whose natural course or treatment could affect the safety or efficacy evaluation for this study.