Category: Genitourinary Cancer

Aligned with Cancer Cures in Mind

Cancer CureThrough clinical trials, we are able to develop safe and more effective ways to detect, diagnose and treat cancer. All clinical trials have a sponsor, which means there is an organization or person involved in the design and support of the study. The sponsor is usually a pharmaceutical company, academic institution or government body. In the United States, there has been a fairly recent increase in the number of government-sponsored studies.

The majority of cancer clinical trials are led by the National Cancer Institute (NCI)-sponsored cooperative groups. This means that cancer specialists across hospitals, medical centers and community clinics can more easily collaborate with one another through a formalized group. One major advantage of NCI-funded cooperative group clinical trials is the ability to study diseases and/or treatments that may be less interesting or practical for pharmaceutical companies or individual academic centers.

Following a series of recommendations leading to mergers, there are now five main groups in the US that form the NCI Clinical Trials Network (NCTN). One of these main groups, the Alliance for Clinical Trials in Oncology, was formed in 2011 after the merger of Cancer and Leukemia Group B (CALGB), North Central Cancer Treatment Group (NCCTG) and the American College of Surgeons Oncology Group (ACOSOG). These mergers streamlined many research efforts that were previously happening on parallel or competing trajectories.

Weill Cornell Medicine (WCM) has investigators involved in all five of the major cooperative groups, but is most heavily involved in the leadership of the Alliance. Dr. Scott Tagawa, Medical Director of the Genitourinary (GU) Oncology Program, serves as Weill Cornell Medicine’s Principal Investigator for the Alliance and a member of the Board of Directors. Dr. John Leonard serves as Chair of the lymphoma committee and member of other leadership committees.

There are many WCM investigators currently leading studies within the Alliance group. The GU committee has a high level of involvement by our medical oncologists, Drs. Tagawa, Beltran, Molina, Nanus, and Faltas. Additionally, Dr. Barbieri and other urologists from our team have recently become more involved in the Alliance.

We have a long history of participation in the GU oncology studies through CALGB and the Alliance, most recently with completed studies in early stage prostate cancer. These include testing:

  • Dietary intervention in men with low risk disease who are on active surveillance (Clinical Trial ID: 70807)
  • Chemohormonal therapy prior to surgery in men with high risk disease (90203)
  • The addition of antiangiogenic therapy in addition to chemotherapy for advanced urothelial carcinoma (90601)
  • Testing the impact of targeted oral therapies in curbing the spread of cancer in patients with intermediate to high risk, advanced renal cell carcinoma (RCC) (A031203)

Through our cooperative groups, we are currently accruing to studies in advanced prostate cancer and early stage bladder cancer with additional new clinical trials in the works.

Prostate cancer:

Bladder cancer:

The Alliance for Clinical Trials in Oncology is committed to reducing the impact of cancer on people by uniting nearly 10,000 scientists and clinicians across the United States and Canada, from many disciplines, hospitals, medical centers and community clinics. Together we’re discovering, creating, validating and implementing new, more effective strategies to prevent and treat cancer; we’re proud to be part of it!

Dying from Prostate Cancer: Lessons Learned from the PLCO Trial

Screening for any disease, including prostate cancer remains imperfect. One study, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, was a National Cancer Institute (NCI) sponsored study that took place between 1993-2001. The goal of the trial was to investigate the impact cancer screening had on dying from these four common tumor types. There were 76,693 men evaluated in the prostate cancer portion of the study.

While some aspects of this randomized trial remain controversial, including the impact that screening had on dying from prostate cancer, it remains a rich prospective dataset for further analysis, as it is one of the largest longitudinal studies ever conducted of men with prostate cancer.

In the “intervention” arm of the PLCO Screening Trial in which men were randomized to be screened for prostate cancer with annual prostate specific antigen (PSA) blood tests and digital prostate exams, there was still an unfortunate set of men who died from prostate cancer. Because the goal of the trial was to determine the prostate cancer mortality differences between the two arms, an understanding of who died and how they died is extremely important.

In a study led by Weill Cornell Medicine’s Dr. Chris Barbieri, we examined how men died of prostate cancer. Dr. Sameer Mittal presented the results of the research at an oral podium presentation yesterday at the 2016 American Urological Association annual meeting, with full results simultaneously published in European Urology.

Of 38,340 men in the screening arm, 151 died of prostate cancer. After graphing their oncologic courses of diagnosis and treatment, we noted a few interesting trends. The most prominent were as follows:

  • More than 50% of the men who died (81 men) either were never screened before this test or had their first PSA test result that was positive. These men were older and had higher median PSA (13.7). It’s possible that if these men were actually screened and or screened earlier and treated, their deaths from prostate cancer could have been prevented.
  • A subgroup of men who died despite screening were young and had a low median PSA (2.0). Surprisingly, they died within approximately 1.5 years of diagnosis. To put this in perspective, we expect an average man diagnosed with metastatic prostate cancer to live for 5 years, so this is quite unusual. We know that some subsets of prostate cancer do not secrete high levels of PSA and this is an area that needs more research in order to prevent further deaths. We don’t know for sure if these men had neuroendocrine prostate cancer (NEPC), but their rapid disease course seems consistent with this aggressive prostate cancer sub-type.

Despite what some may believe, some men do die of prostate cancer. We continue to research why this is the case in order to prevent further death and suffering from this common disease. These study insights underscore the importance of developing diagnostic biomarkers to better detect aggressive prostate cancers and to best predict the way the cancer will respond to various treatments.

The Cancer Conundrum: To Screen or Not to Screen?

For many cancers, the value of screening is well established. As the saying goes, “knowledge is power” and early diagnosis is usually linked with better outcomes. For prostate cancer, this topic has been more controversial. That’s because many of the tumors we discover through screening are what we call indolent tumors – prostate cancers that may never lead to symptoms or require treatment in their lifetime.

The men who are diagnosed with slow growing prostate cancers can potentially be harmed by the label, particularly if they undergo treatment and have long-term side effects as a result.

We have a number of different screening tools available to both detect the presence of prostate cancer and distinguish between the sub-types that don’t require treatment versus those that need to be treated as early as possible. One of the most common and least invasive ways to screen for prostate cancer is through Prostate Specific Antigen (PSA) testing.

PSA is a blood test that since the early 1990s has been widely used to detect prostate cancers and to follow response to treatment. This blood test is frequently incorporated as part of routine blood testing during annual physical exams for men aged 40 or older. PSA values above a “normal” threshold are associated with a greater risk of prostate cancer.

In 2012, the U.S. Preventative Health Task Force (USPSTF) recommended against routine PSA-based prostate cancer screening for healthy men, regardless of age. This recommendation was based, in large part, on results from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a large randomized trial designed and funded by the National Cancer Institute (NCI) to determine the effect of PSA screening on prostate cancer deaths in the United States. At the time, it was determined that there was no benefit to PSA testing.

Contrary to this landmark study, a new study led by Jim Hu, MD at Weill Cornell Medicine and NewYork-Presbyterian found evidence that now demonstrates that PSA testing can help reduce the number of fatal cases of prostate cancer.

DrJimHuProstateCancerScreening

Researchers from the Genitourinary Oncology Program at NewYork-Presbyterian and Weill Cornell Medicine will be presenting their findings at the 2016 American Urology Association (AUA) Meeting on Monday, May 9. They discussed their findings in this week’s New England Journal of Medicine in a letter to the editor questioning the results of the PLCO trial due to limitations in the study’s methodology.

According to this letter, more than 80% of the participants in the PLCO control group (who were not supposed to have PSA tested) reported having had PSA testing within three years of starting the trial or during the trial. Thus the trial was not truly studying men who had not been screened in contrast to those who had been screened.

Dr. Jonathan Shoag, urology resident and lead author on the article further explains, “We demonstrate that the PLCO study did not compare a group of men who received PSA screening to a group of men who were not screened, but compared men who were screened to other men who were screened, and we should therefore reconsider any decisions based on the study.”

While PSA testing isn’t perfect (PSA can rise due to other conditions aside from prostate cancer), it can be a very good screening tool when viewed as one piece of the larger puzzle of what’s going on in the body.

Stay tuned for additional blog updates on the topic. Next week, we’ll have continuing coverage on research from the 2016 AUA meeting, including updates on PSA as a prostate cancer screening tool, other ways to detect prostate cancer, and additional biomarkers that can be used to distinguish between aggressive and non-aggressive prostate cancers.

Together, this information allows us to see a clearer picture of what’s going on in the body in order to increase our cure rates and the number of people we’re able to treat effectively, while simultaneously minimizing interventions for those who don’t need them.