Apalutamide Submitted for FDA Approval in Prostate Cancer

Excerpt:

“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.”

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New Targeted Alpha Therapy Protocol for Advanced Prostate Cancer

Excerpt:

“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.”

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Ipilimumab vs Placebo in Metastatic Chemotherapy-Naive, Castration-Resistant Prostate Cancer Without Visceral Metastases

Excerpt:

“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.”

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Novel Blood Test May Identify New Biomarker in Prostate Cancer

Excerpt:

“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).”

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Metformin Use Does Not Increase Prostate Cancer Survival

Excerpt:

“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 cancer and treated with docetaxel. Patients were stratified into groups based on diabetes status and use of antidiabetic medications to assess the effect of use with docetaxel on survival.”

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Blood Test Instead of Biopsy for Metastatic Prostate Cancer

Excerpt:

“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).”

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Optimizing Treatment With Radium-223 for Prostate Cancer

Excerpt:

“As oncologists await future treatment advances in metastatic castration-resistant prostate cancer (mCRPC), the key is to unleash the full potential of available therapies, Robert Dreicer, MD, asserted during the 2016 CFS Chemotherapy Foundation Symposium.

“One agent that oncologist are focused on optimizing, Dreicer said, is radium-223 (Xofigo). Optimal use of this treatment remains mostly unknown, with current efforts focusing on exploring the agent’s potential in combination regimens.

“For instance, a phase III trial is randomizing patients with bone predominant mCRPC to radium-223 plus abiraterone acetate (Zytiga) or abiraterone alone (NCT02043678). Additionally, a randomized phase IIa study is evaluating the efficacy and safety of radium-223 in combination with abiraterone or enzalutamide (Xtandi) in patients with mCRPC to investigate bone-scan response, radiological progression-free survival, overall survival, and skeletal events (NCT02034552).”

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New Therapeutic Agent Proves More Effective Treatment for Advanced Prostate Cancer

Excerpt:

“A German multicenter study, initiated by the German Society of Nuclear Medicine, demonstrates that lutetium-177 (Lu-177)-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). The study is published in the January 2017 issue of the Journal of Nuclear Medicine and is the featured article.

“Prostate-specific membrane antigen (PSMA) is overexpressed in and even more so with castration-resistant disease. This makes development of new tracers for PSMA-targeted radionuclide therapies a promising treatment approach. Prostate cancer deaths are usually the result of mCRPC, and the median survival for men with mCRPC has been less than two years.”

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How Highs and Lows in Testosterone Levels ‘Shock’ Prostate Cancer Cells to Death

Excerpt:

“Munich, Germany: A strategy of alternately flooding and starving the body of testosterone is producing good results in patients who have metastatic prostate cancer that is resistant to treatment by chemical or surgical castration, according to new findings.
“In a presentation at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany, today (Thursday), researchers reported that results from 47 men who have completed at least three cycles of bipolar androgen therapy (BAT) showed that the strategy was safe and effective. Prostate specific antigen (PSA) levels fell in the majority of the men, tumours shrank in some men, in several the disease did not progress and this included some whose disease continued to be stable for more than a year. One man appears to have been ‘cured’, in that his PSA levels dropped to zero after three months and have remained so for 22 cycles of treatment, with no trace of the disease remaining. The researchers are planning to treat a group of 60 men in total.”

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