Prostate Cancer

In a posthoc analysis of the phase III SPARTAN trial, lead investigator Julie N. Graff, MD, and colleagues examined the study’s apalutamide (Erleada) arm to determine whether the agent affected metastasis-free survival (MFS), time to metastasis (TTM), and location of metastasis as a function of prostate-specific antigen (PSA) nadir.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population ≥10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

Survival was increased with the treatment of enzalutamide plus standard of care compared with the use of other&nbsp;non-steroidal anti-androgens plus SOC for patients with&nbsp;metastatic hormone-sensitive prostate cancer. Results from an interim analysis&nbsp;of the phase III ENZAMET trial presented at the 2019 ASCO Annual Meeting showed that 80% of men with mHSPC were alive after 3 years with enzalutamide treatment compared with 72%.&nbsp;

Karim Fizazi, MD, PhD, professor and head of the GARD Inpatient Unit, at Institut Gustave Roussy, discusses the impact of darolutamide (ODM-201) on pain and quality of life in patients with nonmetastatic castration-resistant prostate cancer.&nbsp;

Patients with metastatic castration-resistant prostate cancer who received&nbsp;apalutamide plus androgen deprivation therapy had a 33% reduced risk of death compared with patients taking androgen deprivation therapy alone in the phase III TITAN trial. Topline results from the trial were&nbsp;presented at the 2019 ASCO Annual Meeting and simultaneously published in the <em>New England Journal of Medicine.</em>

ARV-110, a PROTAC^&reg; protein degrader, has received a fast track designation from the FDA for the treatment of patients with&nbsp;metastatic castration-resistant prostate cancer who have disease progression following &ge;2 systemic therapies.

Jeremie Calais, MD, discusses the results from a preliminary analysis of a phase II trial investigating 177 lutetium prostate-specific membrane antigen-617 in patients with metastatic castration-resistant prostate cancer.

Case Based Peer Perspectives: Metastatic Castration-Resistant Prostate Cancer

Updated NCCN guidelines in prostate cancer recommend integration of tumor genetic testing into clinical practice for patients with advanced prostate cancer. For patients with regional or metastatic disease, the guidelines recommend testing for homologous recombination gene mutations and for microsatellite instability or mismatch repair deficiency, according to Emmanuel S. Antonarakis, MBBCh.

Metastatic Hormone-Sensitive Prostate Cancer Progression to CRPC

Elizabeth Kessler, MD, explained to a group of physicians in a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation the treatment considerations and decisions she makes when seeing a patient with prostate cancer in the clinic.

In a preliminary analysis of a phase II trial, the radiolabeled small molecule, ¹⁷⁷LuPSMA-617, demonstrated a biochemical progression-free survival of 4 months in a cohort of 64 men with metastatic castrate-resistant prostate cancer.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;April 2019, including several new approvals, a priority review, breakthrough designation, and more.

Apalutamide has been submitted for FDA approval for the treatment of patients with metastatic castration-sensitive prostate cancer.