“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.
“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”
“Although modern immunotherapy has yet to have a breakthrough in prostate cancer to the degree it has had in lung cancer or urothelial carcinoma, combinations with anti–PD-1/PD-L1 agents are beginning to show promise for these patients in clinical trials.
“Currently ongoing is a phase II trial of durvalumab (Imfinzi) in combination with the PARP inhibitor olaparib (Lynparza) in patients with metastatic castration-resistant prostate cancer (mCRPC; NCT02484404). Investigators note that previous data have suggested that 25% to 30% of sporadic mCRPC has DNA-repair pathway defects. Results thus far have demonstrated that the synergy of durvalumab and olaparib proves that the combination may be a viable option for patients with mCRPC who are heavily pretreated. The trial is still accruing.”
“According to results of a phase I/II study, men with metastatic castration-resistant prostate cancer (mCRPC) who received a second course of radium-223 (Xofigo) experienced minimal hematologic toxicity and low radiographic bone progression rates.
“In the study, 29 of 44 patients (66%) received the full course of 6 injections. Median time to total alkaline phosphatase was not reached. Median time to PSA progression was 2.2 months.”
“Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), the manufacturer of the next-generation oral androgen receptor inhibitor announced today.
“Apalutamide inhibits the action of testosterone in prostate cancer cells and prevents androgen from binding to the androgen receptor. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, Janssen noted in a press release.”
“Therapy options are limited for men with advanced-stage, metastatic castration-resistant prostate cancer (mCRPC), but a new treatment protocol offers hope. In the featured article of The Journal of Nuclear Medicine‘s October issue, German researchers report on their recent clinical experience, which establishes a dosing regimen for actinium-225 (225Ac)-labeled targeted alpha therapy of patients with prostate specific membrane antigen (PSMA)-positive tumors. The protocol balances treatment response with toxicity concerns to provide the most effective therapy with the least side effects.”
“In the phase III CA184-095trial reported in the Journal of Clinical Oncology, Tomasz M. Beer, MD, FACP, of the Knight Cancer Institute, Oregon Health and Science University, and colleagues found that ipilimumab (Yervoy) did not increase overall survival vs placebo in men with asymptomatic or minimally symptomatic chemotherapy-naive metastatic castration-resistant prostate cancer without visceral metastases. Ipilimumab was associated with prolonged progression-free survival and a higher prostate-specific antigen (PSA) response rate.”
“By assessing plasma androgen receptor (AR) gene status assessment with multiplex droplet digital PCR (ddPCR), European researchers could predict which patients with castration-resistant prostate cancer (CRPC) were most likely to have poorer outcomes while undergoing targeted therapy, according to results from the PREMIER trial published in the Annals of Oncology.
“Researchers said there was a ‘significant association’ for AR gain and poorer overall survival (OS) for both chemotherapy-naïve patients (HR, 3.98; 95% CI, 1.75-9.10; P <.001) and patients previously treated with docetaxel (HR, 3.81; 95% CI, 2.28-6.37; P <.001). AR gain was also associated with poorer OS for chemotherapy-naïve patients treated with enzalutamide (Xtandi) or abiraterone acetate (Zytiga; HR, 2.18; 95% CI, 1.08-4.39; P = .03) and for patients previously treated with docetaxel (HR, 1.95; 95% CI, 1.23-3.11; P = .01).”
“Metformin use in combination with docetaxel chemotherapy does not significantly improve survival in patients with diabetes and metastatic castration-resistant prostate cancer, according to a study published in the April issue of The Journal of Urology.
“Michelle J. Mayer, from Sunnybrook Health Sciences Centre in Toronto, and colleagues used data from several Ontario administrative health care databases to identify men (older than 65 years) diagnosed with metastatic castration-resistant prostate cancer and treated with docetaxel. Patients were stratified into groups based on diabetes status and use of antidiabetic medications to assess the effect of metformin use with docetaxel on survival.”
“There has been a lot of buzz recently about the use of ‘liquid biopsies’ and how these blood tests that show cancer may be able to replace the need for tissue biopsies.
“The latest study shows that such a test could be useful in metastatic prostate cancer, where the biopsy sample would need to be taken from bone, which is painful, risky, and expensive, says an expert.
“This study used the Guardant360 test and found that cell-free, circulating tumor DNA (ctDNA) was detected in most patients (94%) with metastatic castration-resistant prostate cancer (mCRPC).”