Clinical Trials

Cancer Clinical Study Leads to Video Tool for Prostate Cancer Patients

At Emory, research plays a key role in the mission to serve our patients and their families. Medical advances and improvements to patient care have been made possible by research and volunteer participation in clinical trials. More than 1,000 clinical trials are offered at Emory, making a difference in people’s lives, today.

Recently, a clinical study initiated by Winship Cancer Institute of Emory University, found that providing prostate cancer patients with a video-based education tool significantly improved their understanding of key terms necessary to making decisions about their treatment.

The breakthrough study was led by three Winship at Emory investigators; Viraj Master, MD, PhD, FACS; Ashesh Jani, MD; and Michael Goodman, MD, MPH; and is the feature cover story of this month’s Cancer, the peer-reviewed journal of the American Cancer Society.

In 2013, Master, Jani and Goodman released an Emory study that showed that prostate cancer patients (treated at Grady Hospital in Atlanta) experienced a severe lack of understanding of prostate key terms. The original study showed only 15 percent of the patients understood the meaning of “incontinence”; less than a third understood “urinary function” and “bowel habits”; and fewer than 50 percent understood the word “impotence.”

In response to their findings, the three principle investigators jumped to find a solution to the problem. The latest study explored using a video-based tool to educate prostate cancer patients on key terminology. The physicians predicted that with a better understanding of terms linked to disease, patients would be able to participate in shared and informed decision-making throughout the prostate cancer treatment process.

About the Prostate Cancer Video Trial:

  • 56 male patients were recruited from two low-income safety net clinics and received a key term comprehension test before and after viewing the educational video.
  • The video software (viewed by participants on iPads) featured narrated animations depicting 26 terms that doctors and medical staff frequently use in talking with prostate cancer patients.
  • Learn more by watching this video:

clinical trials for prostate cancer

Results of the Prostate Cancer Video Trial:

Participants who viewed the educational video demonstrated statistically significant improvements in comprehension of prostate terminology. For instance, before viewing the application, 14 percent of the men understood “incontinence”; afterward, 50 percent of them demonstrated understanding of the term.

“This shows that video tools can help patients understand these critical prostate health terms in a meaningful way. The ultimate goal is to give patients a vocabulary toolkit to further enable them to make shared and informed decisions about their treatment options,” says Viraj Master. “Our next goal is to improve the tool further, and study this tool at different centers.”

Learn more about clinical trials at Emory >>

Find a clinical trial at Emory >>

 

Additional Information about the Prostate Cancer Trial:

The research for this study was made possible by a Winship Cancer Institute multi-investigator pilot grant and the contributions of faculty and students from Winship, the Rollins School of Public Health and the Emory School of Medicine.

This study was led by three Winship at Emory investigators: Viraj Master, MD, PhD, FACS, Winship urologist and director of clinical research in the Department of Urology at Emory University; Ashesh Jani, MD, professor of radiation oncology in the Emory School of Medicine; and Michael Goodman, MD, MPH, associate professor of epidemiology with the Rollins School of Public Health.

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Progress and Thanks for Five Years of Phase I Clinical Trials

Phase I AnniversaryPatients.

Clinical trials.

We cannot have one without the other.

The Phase I Clinical Trials Unit at Winship Cancer Institute of Emory University opened in 2009, a time when a significant expansion of clinical trial efforts was underway to support the National Cancer Institute cancer center designation. Over this rapid five-year period, a truly collaborative culture has led to a cutting-edge, early drug development program at a nationally recognized, top 25 cancer center.

None of this has been possible without patients putting their trust in our physicians, nurses, scientists, and many others, to deliver optimal care while asking critical questions about novel drugs and approaches. When I think about the impact of our Phase I unit on patients and their families, I recall a recent conversation with a seasoned oncologist here at Emory. He said, “Donald, if I saw anyone in the chairs here at a store, I wouldn’t know they had cancer.” A simple statement, but one that conveys a number of key messages about how our phase I trials have evolved over five years. Drugs we now have at hand, as a whole, are much safer and better tolerated than conventional chemotherapy. We also have access to more agents with much better activity against cancer, leading to more treatment options.

With improved treatment comes a sense of satisfaction. However, we cannot over-emphasize the critical effect patients have on us as health care providers, researchers, and human beings. As a clinician-researcher, the greatest motivating factor I have is seeing patients do well on trials and coming to visits to talk about trips, family gatherings, important personal events, and the role that treatment on a trial had in helping them live their lives.

For this, we say thank you to our patients and their families for their trust and the courage they show on a daily basis. You keep up your fight, and we will keep up ours.

About Dr. Harvey

R. Donald Harvey, FCCP, BCOPR. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.

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Clinical Trials Responsible for Advances in Medical Treatment

Tamara Mobley, 38 and married with 8 and 12 year old sons, has been battling multiple myeloma for five years now under the care of Dr. Sagar Lonial at the Winship Cancer Institute of Emory University. She went on a clinical trial at Winship in order to get the most advanced drug for treating this blood cancer. Because of that trial, the drug is now FDA-approved and is helping Tamara maintain her active life.

Clinical trials are responsible for most advances in medical treatment, but they can’t take place without volunteer participants like Tamara. Unfortunately, there are still many misconceptions about clinical trials that keep people from participating.

For instance, some believe joining a clinical trial is a last resort in the treatment process, which was not the case for Tamara and many other Winship patients. For Tamara, enrolling in a clinical trial was a good option once her standard cancer drugs stopped working.

In the video below, Fox 5 Atlanta talked to Tamara and Dr. Lonial about the decision to participate in a clinical trial.

Atlanta News, Weather, Traffic, and Sports | FOX 5

It is important to speak with your physician about participating in a clinical trial. For more information about a specific trial, please contact the lead research coordinator.

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5 Actions to Consider When Diagnosed with Cancer

5 Things to ConsiderA common symptom of a new cancer diagnosis is pure and utter bewilderment. The American healthcare system can be a confusing maze involving dozens of options and decisions. Helping someone understand what comes next is an important part of my job as an oncologist and is necessary to assure a patient’s overall wellbeing.

Here are five actions to consider taking after receiving a cancer diagnosis.

  1. Get a second opinion. Before starting any cancer treatment, get at least one additional physician or team of physicians to review your case and give an opinion on both the diagnosis and possible treatment options. In fact, you may be required to get a second opinion by your insurance company. Don’t worry about offending your doctor. Getting a second opinion is a very common practice.
  2. Look for a clinical trial. Tens of thousands of people benefit each year from volunteering to participate in a clinical trial. Clinical trials can provide you with access to treatments not otherwise available, including new drugs and therapies for many types of cancer. Winship Cancer Institute is proud to offer patients access to hundreds of cancer clinical trials.

Phase I Trials – Where All Anticancer Drugs Begin

Donald Harvey, MD

R. Donald Harvey, PharmD, FCCP BCOP, director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials section

Each of the agents we use to treat cancer had a beginning, a first step, in understanding how safe and effective they might be.  As drugs are developed, we ask questions in different ways at each step, or phase, of testing. The National Cancer Institute reminds us that clinical trials are available for all patients at all points in their cancer journey, not just for patients with advanced cancer that is not responding to treatment.

When a drug is first given to patients, it enters testing in a phase I trial, where we ask questions such as:

  • What is the right dose?
  • How should it be given (e.g., by mouth, by vein, under the skin)?
  • What is the right schedule of treatment?
  • What side effects are there and how severe are they?
  • How often do we see side effects?
  • Where did the drug go in the patient? How well was it absorbed? How was it metabolized and/or eliminated? (Pharmacokinetics)
  • What did the drug do to the patient, both in blood and at the site of the cancer? (Pharmacodynamics)

Patients courageous enough to enter phase I trials are asked to do many time-consuming but important things during the trial. Frequently, patients are asked to spend 10-12 hours in our clinical trials unit and/or come in daily up to 14 times during the first treatment period, or cycle. During these visits, blood is drawn, tumor or bone marrow biopsies may be performed and safety tests are conducted, all in an effort to get a complete picture of drug effect, disposition and side effects.

Participation in phase I clinical trials:

To participate in a phase I trial, patients typically have cancer that has not been effectively treated with other therapies, and most trials require patients to be otherwise relatively healthy. Phase I trials usually enroll 10-40 patients, but may be larger or smaller depending on the questions being asked. Two types of phase I trials exist: those where the drug is being given for the first time, or first-in-human trials; and those where there is prior experience and the drug is given in combination with another drug or drugs (also called phase IB trials). In each, the investigational agent is given to small groups of patients, and doses are increased in each group. Both types are critical to the next step of development to define the dose, frequency, and understand what cancer types are most likely to benefit.

Phase I trials help to determine the future of drugs in cancer treatment. Right now, the large number of new agents in early testing indicates great potential in the transformation of therapy. People in good health may choose to participate in clinical trials simply to help researchers find better treatments. Participation in clinical trials is completely voluntary, but you should also speak with your physician before deciding to enroll.

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About Dr. Harvey

R. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.

New Treatment for Prostate Cancer: Saint Joseph’s Hospital First in State to Treat Patient with Xofigo

Xofigo new prostate cancer treatment medicationA double bass player in the Atlanta Symphony Orchestra, Doug Sommer claims he was just “in the right place at the right time with the right doctors,” when he was offered the opportunity to be the first in the state to receive a new treatment option for his prostate cancer.

Doug is the first patient in Georgia to receive a new FDA-approved radioactive therapeutic drug for advanced metastatic prostate cancer. He received the treatment, a single injection of radium Ra 223 dichloride, (brand name Xofigo) at Saint Joseph’s Hospital. This was the first of six injections. Xofigo has been shown to reduce bone pain and improve quality of life.

“Patients with a type of cancer called castration-resistant prostate cancer (CRPC) with metastatic bone disease, who have failed hormone suppression therapy, now have a new treatment option for their disease.”

Peter Rossi, MD, medical director of radiation oncology at Saint Joseph’s Hospital and assistant professor of radiation oncology at Emory University School of Medicine & Winship Cancer Institute

Read more about this new treatment for prostate cancer on the Saint Joseph’s Hospital blog >>

A More Precise Blood Test Outperforms PSA Screening in Detecting Aggressive Prostate Cancers

Martin Sanda, MDMartin Sanda, MD, a member of the Winship Cancer Institute, chairman of the Emory Department of Urology and internationally recognized prostate cancer scientist, recently delivered big news about better prostate cancer diagnosis, at the American Urological Association’s 2013 Annual Meeting.

As corresponding and presenting author of the abstract “Prostate Health Index (phi) for Reducing Overdetection of Indolent Prostate Cancer and Unnecessary Biopsy While Improving Detection of Aggressive Cancers,” Sanda presented findings that represent a significant step towards better detection and diagnosing of fast-growing prostate cancers, and fewer unnecessary biopsies of indolent cancers.

The Prostate Health Index (phi), a blood test used to evaluate the probability of prostate cancer diagnosis, outperformed commonly used prostate-specific antigen (PSA) and free/total prostate-specific antigen (%fPSA) tests in predicting the presence of clinically significant prostate cancer and in improving prostate cancer detection, according to the new study. The phi test focuses on measuring a subtype of PSA, called pro-PSA, that unlike the rudimentary total PSA, is preferentially made by aggressive prostate cancers and less so by normal prostate or slow-growing cancers. Sanda and his collaborators found that among men being considered for prostate biopsy due to abnormal results on the traditional “total” PSA test, one in four had phi test results that indicated no aggressive cancer would be found and unnecessary biopsy could be averted.

To learn more about this exciting new screening test, read the full story in the Emory News Center. For more prostate cancer and PSA screening related articles, check out our related resources at the end of this post.

About Martin Sanda, MD

Martin G. Sanda, MD is chair of the Department of Urology at Emory University School of Medicine and Urology service chief for Emory Healthcare. Before joining Emory in 2013, Sanda was Professor of Surgery in Urology at Harvard Medical School, Director of the Prostate Cancer Center at Beth Israel Deaconess Medical Center and co-leader of the Prostate Cancer Program at the Dana Farber Cancer Center.

As a urological surgeon specializing in cancers of the prostate and bladder, Sanda focuses on developing new surgical and non-surgical approaches to cancer care and to improving the quality of life among cancer survivors.  Currently, he is spearheading studies that seek to develop urine tests for detecting prostate cancer; develop benchmarks for improving quality of life among cancer survivors; and develop innovative prostate cancer vaccines.

Sanda has served as chair of the Prostate and Genito-Urinary Collaborative Group of the National Cancer Institute’s Early Detection Research Network (2007-2010), has led two nationwide, NCI Cooperative Group prostate cancer clinical trials, and has served on the Research Council of the American Urological Association since 2011.  Dr. Sanda will also serve as Director of the Prostate Cancer Center, being established within the Winship Cancer Institute of Emory University.

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The Skinny on Neuroendocrine Cancer

Neuroendocrine tumors develop in the cells of the neuroendocrine system, a network of glands throughout the body that produce hormones. Neuroendocrine tumors are rare, typically affecting 1 – 2 people per 100,000 people.

The different types of neuroendocrine tumors depend on the particular cells that are affected.  They usually develop in the digestive system and the lungs.  Approximately 38% of tumors are in the appendix, 23% in the ileum (also known as carcinoids), 13% in the rectum and 11.5% in the bronchi.

Symptoms of Neuroendocrine tumors

Neuroendocrine tumors may be slow growing (low grade or well differentiated) or rapidly growing (high grade or poorly differentiated).  They may be functional (release hormones) or nonfunctional.  When functional neuroendocrine tumors release a variety of hormones including a hormone called serotonin, a condition called carcinoid syndrome may occur. Symptoms most commonly associated with neuroendocrine tumors include flushing, diarrhea, weight loss, abdominal pain and cramping.   Patients with carcinoid syndrome may also experience cardiac changes, which are caused from fibrotic damage to the heart.  Usually a patient with carcinoid syndrome does not experience these symptoms until the tumor has spread within the body.

Other terms used for neuroendocrine tumors include
• Gastroenteropancreatic neuroendocrine tumors – tumors in the gut or pancreas
• Pancreatic neuroendocrine tumors – also known as islet cell cancer, or PNET
• Gastrointestinal neuroendocrine tumors – tumors that develop in the bowel, stomach or esophagus
• Pheochromocytoma of the adrenal gland
• Carcinoid tumors of the lung or intestinal tract
• Carcinoid Syndrome
• Gastrinoma, Insulinoma, Glucagonoma, VIPoma (vasoactive intestinal peptide tumor)

Treatment of neuroendocrine tumors

Treating neuroendocrine tumors can be a challenge due to the various types, locations in the body, the symptoms they produce and the diverse number of treatment modalities. Treatment is individualized to  each patient but can include surgery, liver directed therapy, medications, and/or radiation.

When treating a rare, challenging cancer such as neuroendocrine cancer, it is important to have a team of healthcare professionals at your side who are experts in the  disease and can collaborate to create a treatment plan individualized to each patient.

At Winship Cancer Institute of Emory University, we take this multidisciplinary approach with teams of  expert medical oncologists, surgical oncologists, interventional oncologists, gastroenterologists, pulmonologists, endocrinologists, nurses, and dieticians ( just to name a few) to create a care plan unique to each patient.

About Bonnie Josaphs, RN, BSN, OCN

Ms. Josaphs received her Bachelor of Science in Nursing from the University of Delaware, Newark, Delaware in 2002. She has been practicing within Gastrointestinal (GI) Oncology since 2004.  She specializes in gastrointestinal cancers which include cancers of the esophagus, liver, colon, rectum, pancreas, gallbladder and stomach.

Related Links

More information on neuroendocrine tumors:
Winship Cancer Institute Clinical Trials for Neuroendocrine Tumors
 The Winship Cancer Institute of Emory University is Georgia’s only NCI-designated Cancer Center.

Canine Brain Tumor Trial Shows Promising Results!

Petey cancer clinical trialFox 5 News health reporter Beth Galvin features the first “patient” in a Brain Tumor trial that combined surgery with a new experimental agent. Petey, a dog, is a part of a research trial aimed at translating new brain cancer therapies to humans by assessing results in dogs with similar diseases.

Winship Cancer Institute of Emory University neurosurgeon, Costas Hadjipanayis, MD, PhD, developed the experimental agent in his Brain Tumor Nanotechology Laboratory. Petey’s tumor was partially removed in surgery at the University of Georgia (UGA) College of Veterinary Medicine, and the new, investigational drug was infused directly into the tumor area. Now, 15 months later, his tumor has shrunk and Petey is seizure-free and doing well. Watch the full story here:

 

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