Evaluating the effectiveness of degarelix with or without apalutamide before prostate surgery in patients with high-risk prostate cancer.

This study evaluated the effectiveness of degarelix (Firmagon) with or without apalutamide (Erleada) before radical prostatectomy (RP; prostate surgery) in patients with high-risk prostate cancer (PC). The data showed that degarelix plus apalutamide significantly improved the pathological response in these patients.

Localized prostate cancer (PCa) is a form of cancer that has not spread beyond the prostate gland. PCa can be treated by surgery to remove the prostate called radical prostatectomy (RP). Almost 15-40% of men who undergo RP as a treatment for PCa experience biochemical recurrence (BCR). BCR means an increase of 2 ng/ml from the lowest value of the prostate-specific antigen (PSA; a protein made by the cells of the prostate gland).

Another treatment option is hormone therapy (HT) such as androgen deprivation therapy (ADT). ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens prevents cancer cell growth. Quite often, ADT is administered to reduce tumor size prior to other treatments such as radiotherapy or surgery. This is referred to as neoadjuvant hormone therapy (NHT).

Gonadotropin-releasing hormone (GnRH) receptor antagonists (blockers) are a type of ADT. Degarelix is a commonly used GnRH blocker given as an injection. Apalutamide is an anti-androgen medication. It blocks testosterone from reaching PC cells. Apalutamide plus ADT improves outcomes like overall survival and lowers the risk of disease progression and spread in men with PC. However, the effectiveness of degarelix with or without apalutamide before RP in patients with high-risk PCa is still unknown.

This study involved 89 men with high-risk PC. Patients were randomly assigned to two groups. Group 1 included 45 patients who received degarelix plus apalutamide. Group 2 included 44 patients who received degarelix plus a placebo. All patients then underwent RP.

The minimum residual disease (MRD) response rate (MRD; a small number of cancer cells left after treatment) was 38% in group 1 compared to 9.1% in group 2. This difference was statistically significant.

There were no significant differences in terms of serious side effects, quality of life, sexual function, and urinary incontinence (involuntary urine leakage) between the two groups.

This study concluded that degarelix plus apalutamide before RP significantly improved the pathological response in patients with high-risk PCa.

This study was funded by Janssen, the manufacturer of apalutamide. This study mostly included Caucasian patients. Larger studies with longer follow-up periods are needed to validate the conclusions.