Prostate Cancer

On June 20, 2023, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (HRR) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.

An analysis from the ARASENS trial showed that the addition of darolutamide to androgen-deprivation therapy and docetaxel significantly improved overall survival in subgroups of patients with metastatic hormone-sensitive prostate cancer with high-volume and high-risk disease and should be considered the new standard of care for this patient population.

A shortened course of radiation therapy is safe and effective for men with high-risk prostate cancer, according to the results of the phase 3 Prostate Cancer Study 5 (PCS5) trial. These findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 by the study’s lead investigator Tamim M. Niazi, MD, Associate Professor, Radiation Oncology, and Radiation Oncologist, Jewish General Hospital, McGill University, Montréal, Québec, Canada.

The addition of the PARP inhibitor niraparib (Zejula) to abiraterone acetate (Zytiga) plus prednisone (AAP) led to a significant improvement in radiographic progression-free survival (PFS) versus AAP alone in men with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations, according to the final analysis of the primary end point of a phase 3 trial.

Treatment with the androgen receptor inhibitor darolutamide (Nubeqa), in combination with androgen-deprivation therapy (ADT) and docetaxel, significantly improved overall survival (OS) compared with ADT and docetaxel alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to recent results from the phase 3 ARASENS clinical trial, which were simultaneously published in the New England Journal of Medicine.

The use of a polygenic score (PGS) based on noncancer genetic variations in prostate-specific antigen (PSA) values helped to refine PSA screening in a large group of men without prostate cancer at baseline. The use of the PGS to adjust PSA allows identification of aggressive versus low-risk prostate cancer and can potentially reduce unnecessary biopsies, said the lead investigator of a large genome-wide association study (GWAS) presented at the 2022 American Association for Cancer Research annual meeting.

Two years of abiraterone acetate (Zytiga) plus prednisone added to androgen-deprivation therapy (ADT) improved metastasis-free survival and overall survival compared with ADT alone in men with nonmetastatic castration-sensitive prostate cancer, whereas the addition of enzalutamide (Xtandi) to ADT had no benefit, and much greater toxicity.

The addition of ¹⁷⁷Lu-PSMA-617, a radionuclide therapy that targets prostate-specific membrane antigen (PSMA), to standard-of-care treatment resulted in a 38% reduction in the risk for death versus standard of care alone in men with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), according to findings from the phase 3 VISION clinical trial, which were presented during a plenary session at the ASCO 2021 virtual annual meeting.

On December 18, 2020, the FDA approved relugolix (Orgovyx; Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of adults with advanced prostate cancer. Relugolix is the first oral androgen-deprivation therapy (ADT) and the first oral GnRH receptor antagonist approved for patients with advanced prostate cancer. The FDA granted relugolix priority review for this indication.

On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels.