Promising Research Brings New Hope for Men with Aggressive Prostate Cancer

misha-beltra_esmo_img_2611Earlier this month, Dr. Himisha Beltran presented exciting new research results for those with metastatic prostate cancer at the European Society of Medical Oncology (ESMO)’s annual meeting in Copenhagen, Denmark. Cancer experts and patients from around the world came to the 2016 ESMO Congress to discuss the latest research and cutting-edge treatment options for people with cancer.

Dr. Beltran’s research presentation highlighted promising results from a clinical trial for men with aggressive prostate cancer. Aggressive prostate cancer sub-types represent approximately 25% of all prostate cancer cases, and neuroendocrine prostate cancer (NEPC) is considered to be the sub-type that is most resistant to currently-available treatments.

Dr. Beltran and the Weill Cornell Medicine (WCM) Genitourinary (GU) Oncology team led this multicenter, phase 2 clinical trial, which was based upon prior WCM work which identified aurora kinase A as a key target in NEPC. The trial enrolled sixty patients from across the United States. It was the first clinical trial to study a new, targeted treatment for men with NEPC. The drug used in this study, Alisertib, is an oral medication that is an Aurora Kinase A Inhibitor.

This clinical trial confirmed our hypothesis that different men’s tumors genetically expressed different levels of the targets for the drug, and as a result their response rates to this treatment varied. Those with the most optimal responses had cancers that genetically appeared to be most like NEPC in both biopsies and whole exome genomic sequencing of the tumor. As part of our Institute for Precision Medicine, we use the Exact-1 whole exome sequencing test to categorize more than 21,000 genes within the tumor. This is the most comprehensive way to determine where mutations and mechanisms for treatment resistance may exist in patients with advanced stage cancer and allows us to narrowly target different patient’s treatment regimens on the molecular level. In addition, some of the tumor biopsies were analyzed for gene expression (RNA) and organoids, which are tumor models that we are able to grow from the biopsy tissue, were developed.

In this clinical trial, we were able to learn a lot on the molecular level from the patients who had the most exceptional responses to Alisertib. Based on these results and establishing biomarkers to predict Alisertib response rates, future clinical trials could be much more targeted to include only the men whose tumors indicate that they are likely to respond to this therapy.

Additionally, there is great potential to learn much more about the tumor evolution and the biology of resistance. This clinical trial underscores the need to more narrowly focus on the sub-set of prostate cancer patients with NEPC, as there are few standard treatment options and limited clinical trials available for these men.

Thank you to all the men who enrolled in this clinical trial and helped further the field of research in the search for new cures for prostate cancer.

We’re always working to increase access to new promising treatments for NEPC and other aggressive forms of prostate cancer through clinical trials. To learn more about our open studies and to make an appointment with the Weill Cornell Genitourinary (GU) Oncology Program, call 646-962-2072.

Diagnosis Decisions: Is Active Surveillance the Right Prostate Cancer Treatment Choice for You?

jch9011We’re launching a new blog series to help provide some direction to the decision making process that typically follows a cancer diagnosis.

To kick off the series, we sat down with Dr. Jim Hu, one of our internationally-renowned urologists, to determine some of the factors that should go into the decision to pursue active surveillance as a prostate cancer treatment approach.  

A cancer diagnosis typically involves much more than just detecting the presence of cancer in the body. Additional information about the nature of the cancer and where it started and may have spread helps physicians recommend the best course of treatment, especially since depending on cancer type (very low, low, intermediate or high risk), there can be a wide ranging degree of aggressiveness.

For most types of cancers, there are different standards used to “grade” or assess this aggressiveness on a common scale. Usually this information is then used in conjunction with information about whether the cancer has already spread or metastasized to other parts of the body. It can also be used alongside other genetic and molecular information about the cancer that tells us whether this specific cancer is likely to respond to a certain treatment and the rate at which the cancer is likely to spread.

For a long time, prostate cancer has been known as an “indolent” or slow-growing cancer relative to other cancers such as pancreatic or lung cancers. The aggressiveness or rate at which it is likely to grow is measured by studying the appearance of the cancer cells under a microscope to determine the grade. For prostate cancers, we refer to this as the Gleason score. The lowest prostate cancer grade is currently Gleason 3+3=6. Grade 6 prostate cancer is thought to be non-aggressive and unlikely to spread to other places in the body.

However, there are cases when more aggressive cancer may have been hidden and then subsequently discovered. The challenge is that in 75% of cases, prostate cancer is multi-focal, meaning that it grows within several areas of the prostate. This makes it difficult to accurately stage the tumor entirely, as only one section of the cancer is being analyzed to determine its aggressiveness. As a result, the decision to pursue active surveillance or careful monitoring and watching in patients with low-grade tumors on the Gleason scale depends on several factors. These factors include a man’s overall health, life expectancy, the age of diagnosis, and personality type.

The rationale for this approach is that low-risk prostate cancer grows very slowly and some question whether it ever spreads. Therefore the majority of these cancers may not be life threatening within a 10 year time frame, so men can avoid prostate cancer therapies that may affect quality of life. For this group, active surveillance is an alternative to the over-treatment of prostate cancer and potential side effects that can come along with it For example, in men who have numerous medical conditions and a shorter life expectancy, active surveillance is a reasonable treatment option, even with Gleason 3+4=7 prostate cancer, or intermediate risk disease.

With active surveillance, it is important to be monitored regularly by a urologist who will test your PSA levels and perform digital rectal examinations of the prostate. Imaging with Magnetic Resonance Imaging (MRI) and targeted biopsy of suspicious areas should also be part of the routine to accurately assess prostate cancer severity.

Targeted biopsies use ultrasound fused to the MRI to guide the procedure, greatly increasing the accuracy and likelihood that the tissue sample is of the most suspicious section of the prostate. A guided biopsy takes approximately 10 minutes and carries a small risk of infection or bleeding (like a standard biopsy). Many academic medical centers, including Weill Cornell Medicine/NewYork-Presbyterian Hospital offer targeted biopsies, but many community practices do not. Additionally, there is a learning curve to the procedure, so the experience of the urologist is critical.

There are also biomarkers that have recently been developed to evaluate the need for a prostate biopsy. These include the 4K test and Prostate Health Index (PHI), which are blood tests that assess the likelihood that prostate cancer may be contributing to a rise in PSA level.

Additionally, for men diagnosed with low risk prostate cancer, there are new tests that assess the genetics of the tissue to determine whether more aggressive disease may have been missed on the biopsy, and present in other parts of the prostate. These assays are called Oncotype Dx, Decipher and Polaris.

We offer all of these tests at Weill Cornell and NewYork-Presbyterian, and together they paint a much more complete picture of the prostate cancer and whether it is progressing. This comprehensive, big picture is what we use to make recommendations for your overall course of prostate cancer treatment, including whether it would be a good idea to pursue active surveillance.

Moonshot Summit: Changing Cancer As We Know it

DAVID NANUS, MD

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Photo credit: Ira Fox

On June 29, Weill Cornell Medicine and NewYork-Presbyterian Hospital joined more than 270 institutions across the country in holding a Moonshot Summit. These summits were held in conjunction with Vice President Biden’s Moonshot initiative to fight cancer. On this national day of action, cancer experts throughout our institution, survivors, and advocates came together to share their ideas for increased collaboration and cures.

The summit conversation started with a constructive dialogue about clinical trials and the unfortunate fact that for many cancer types, the “standard of care” chemotherapies are not good enough. At Weill Cornell Medicine and NewYork-Presbyterian, immunotherapies and precision medicine are opening new doors in cancer treatment, but sadly not all patients currently have access to these types of cutting-edge treatments.

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A packed room at the Weill Cornell Medicine/NewYork-Presbyterian Hospital Cancer Moonshot Summit (photo credit: Ira Fox)

Clinical trials may have gotten a bad rap in the past, but they are a powerful tool to access innovative treatments. The speakers agreed that clinical trials should be easily accessible to all patients, but at times there are obstacles. These range from lengthy forms that deter enrollment, to bureaucracy that slows the timeline for opening new clinical trials, to disinterest and concerns about the treatments’ effectiveness. On a global scale, there has been a lack of adult participation in cancer clinical trials, while for children we actually see the opposite trend – very high enrollment. What can we learn from this information?

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(L-R) Dr. Gail Roboz and Dr. Susan Pannullo speaking at the Cancer Moonshot Summit (photo credit: Ira Fox)

One of my colleagues Dr. Gail Roboz wisely stated, “I always tell my patients, be afraid of the disease, not the treatment.” She’s right in that we need to reframe the conversation to focus on making strides in increasing cure rates through new research that leads to new treatment breakthroughs across disease states.

We also talked about access to care. Not all patients are able to get a correct diagnosis quickly. This can be due to a variety of reasons including a lack of access to specialists, living in a rural area, or financial limitations. By increasing government research funding, as well as making it easier for patients to reach quality care, we can remove some of these barriers nationally. If we increase the number of people who are diagnosed with cancer early on, we can increase the cure rates. Additionally, as a country, we need to provide comprehensive care for patients and families and always put the interests of patients first. This includes offering supportive services beyond just the best medical care.

I felt so empowered by my colleagues and our patients’ great ideas about how we can overcome the challenges we face in cancer care. The Cancer Moonshot initiative is giving high hopes to many and will help ultimately change the world of cancer care as our country stands together with common goals and a renewed commitment to collaboration. By bringing everyone together at an event like this, we hear diverse perspectives and glean new insights. The fight against this terrible disease truly unites us all.

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Photo credit: Ira Fox