The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the third androgen receptor inhibitor to be approved for this indication; apalutamide (Erleada) and enzalutamide (Xtandi), which are also approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC), were approved earlier.

Tamsulosin (Flomax - Boehringer Ingelheim), an alpha 1 - adrenoreceptor blocker, has been approved by the FDA for treatment of benign prostatic hyperplasia (BPH). It is claimed to bind preferentially to alpha1 receptors in the prostate.

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

A study recently published in the New England Journal of Medicine concluded that dutasteride (Avodart – GlaxoSmithKline), a 5α-reductase inhibitor marketed for treatment of symptomatic benign prostatic hyperplasia, reduced the risk of prostate cancer over a 4-year period.

The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

Dutasteride (Avodart - GlaxoSmithKline) is now available in the US for oral treatment of benign prostatic hyperplasia (BPH). It is similar to finasteride (Proscar - Merck), which has been marketed for this indication since 1992 and also, since 1998, for alopecia (Propecia - Medical Letter 1998; 40:25).

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

The Prostatron, a microwave device manufactured by EDAP Technomed in Cambridge, MA, has been approved by the US Food and Drug Administration for treating symptoms of benign prostatic hyperplasia (BPH).

Abarelix (Plenaxis - Praecis Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) antagonist, has been approved by the FDA for treatment of advanced symptomatic prostate cancer in patients who should not take luteinizing hormone-releasing hormone (LHRH) agonists and who refuse treatment with surgical castration.