The national clinical trial to compare prostate cancer patient outcomes following proton therapy or photon (X-ray) therapy is underway. According to COMPPARE and Proton project manager Adrienne Greenewalt, the first five sites participating in the study are activated and accruing patients.

The clinical trial is known as COMPPARE which stands for “A Prospective COMparative Study of Outcomes with Proton and Photon RAdiation in PRostate CancEr (COMPPARE).” This study is funded by the Patient-Centered Outcomes Research Institute (PCORI) and led by Nancy P. Mendenhall, MD, at the University of Florida. COMPPARE will ask 3,000 prostate cancer patients (ages 30-80) across the United States who have chosen to be treated with proton therapy or photon therapy to answer brief surveys regarding treatment choice, quality of life, and side effects for at least three years.

In addition, proton therapy patients can choose to participate in a randomized trial in which half will be randomly assigned to the standard course of therapy and the other half will receive a shorter “hypofractionated” course in which the total dose of radiation will be divided into larger doses with fewer treatments. This additional study will evaluate whether quality of life, side effects, and cure rates differ between patients receiving standard therapy versus shorter therapy.

The goal of the study is to answer the following patient-centered questions:

1. How likely are men to experience different quality of life issues with protons versus photons?
2. How likely are men to experience different side effects with either treatment?
3. Which treatment will result in a better cure rate?
4. Is a shorter, higher dose treatment regimen as safe and effective as a longer, lower dose treatment regimen?

Because men of African descent are 1.6 times more likely to be diagnosed with prostate cancer and more than twice as likely to die from it, the study team is actively working to recruit Black men to this study and assess whether quality of life, side effects and cancer recurrence outcomes differ for these patients.

Participants in the study over the first three years will receive up to $250 for completing surveys before radiation begins, during treatment, and at follow-up visits. For more information about the study, visit www.comppare.org. Research reported in this study website was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-2017C1-0422). The views, statements, and opinions presented in this study website are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.

The 15^th Annual Play Golf. Fight Cancer.^® Classic to benefit the proton research program at the UF Health Proton Therapy Institute will take place October 21, 2019 at the World Golf Village, St. Augustine, Florida.

Sponsorships are available with various levels that include foursomes, recognition on promotional materials and signage, and sponsor’s logo displayed on the website, social media and player gift. Call 904-588-1423 to speak to the sponsorship director or email playgolffightcancer@floridaproton.org . Foursomes and individual players can register online at www.playgolffightcancer.org.

According to Nancy P. Mendenhall, MD, professor and associate chair of UF Health Radiation Oncology and medical director of the UF Health Proton Therapy Institute, the generosity of past participants has made it possible to perform research that is changing the way cancer treatment is handled in the United States and around the world.

“Please, join us for a fun event as we Play Golf. Fight Cancer.^® Together, we can help current and future cancer patients from Florida and around the world get the care – and the confidence – they need to live a happier, healthier and longer life,” said Mendenhall.

By Theresa Edwards Makrush

When Kalpana Nagraj and Prasanna Venkatesh learned that tumor remnants in their 10-year-old son Arjun’s brain showed signs of growing after 16 months of remission following surgery they were surprised. Arjun was not experiencing any symptoms said his father Prasanna. The change, however, was visible on the imaging scan done as part of regular monitoring of his condition. His doctors in Sydney, Australia, recommended radiation therapy.

Kalpana, Arjun’s mother, said at the time of his initial diagnosis in August 2017, he had recently passed a rigorous academic exam and was placed in one of the top schools for gifted and talented students. Through their discussions with the radiation oncologist in Sydney and their independent research, they were aware of the potential treatment-related risks to cognitive function. “We didn’t want the effects of radiation to affect his future prospects given he is a very bright child,” she said 

Arjun’s parents with strong support from their local radiation oncologist, endocrinologist and general practitioner began researching options, including a Facebook page for parents whose children have been diagnosed and treated for craniopharyngioma – a tumor so rare it is estimated to affect two people in a million. There they got in touch with a family from Australia who had a child treated with proton therapy at the UF Health Proton Therapy Institute. Encouraged by what they learned, they reached out to the experts at the Institute as they wanted Arjun to reach his maximum future potential.

They also looked into other proton therapy centers around the world, there are none in Australia, and were therefore confident in choosing the UF Health Proton Therapy Institute for Arjun’s treatment. “When you look at the medical research about craniopharyngioma, Dr. Danny is one of the world’s best. They are the leader in the field, and UF Proton has had the most success in treating children with craniopharyngioma,” said Prasanna.

They were connected with Amy Sapp, RN, BSN, director of pediatric nursing, and Daniel J. Indelicato, MD, director of the University of Florida pediatric radiotherapy program and associate professor of radiation oncology. “We had interaction with Amy and Dr. Danny before we got here. They sent the information to our doctor to quickly make a decision, and enabled us to process the Medical Treatment Overseas Program, or MTOP, paperwork. Their responsiveness was fantastic,” said Kalpana and Prasanna.

Within two weeks of approval by the MTOP, the family, including six-year-old daughter Avika, made the journey to Jacksonville arriving on March 11. Heather Oakley, LCSW, OSW-C, director of social services and pediatric oncology social worker, helped arrange housing and transportation making the experience easy. “They organized for us to get picked up at the airport. They took us directly to Walmart to shop. We had everything in hand,” Kalpana said. She was delighted to learn about the loan closet at the Institute where she found everything from a tea kettle to an X-box complete with games to entertain the children. “You don’t have to feel like you need to bring everything from home,” said Kalpana.

Prasanna said that because of the support network at the Institute, families should not be afraid of being out of their comfort zone if they need to travel for treatment, especially when you want to give your child the best treatment possible. “If the fear is you have to go to the other side of the world, it’s not daunting because the support network is here.” Kalpana added, “We actually felt like we were at home.”

Arjun has not had any acute side effects while having proton therapy. His neurological evaluation indicates that he is in the top percentile for his age with no loss of cognitive function, his parents said. He has Skyped with his teacher in Australia to keep up with his studies, and is preparing for a national level exam in May. Kalpana said he’s taking good care of himself, making sure to eat healthy foods and to exercise – his favorite is swimming the freestyle stroke and the backstroke – doing everything he can to get well. She said, “He’s an old soul in a young body. He’s a very motivated child with a fighting spirit, and UF Proton and their wonderful, amazing team have ensured Arjun receives the best.”

The family enjoyed participating in the many activities hosted by the social services team at the Institute, including Family Fun Night, support groups and outings to shows and theme parks. Jennifer Duncanson, MS, CCLS, child life specialist, was excellent and supportive and helped organize all tickets. Staying active and connected helped the family keep a sense of normalcy said Prasanna.

Kalpana said the art table in the lobby staffed daily by artist-in-residence Pamela Gardener was especially beneficial. Arjun said, “Everyone is very friendly. Pam entertains me and makes me happy every time I come here.” Kalpana and Avika also enjoyed the art table, and Kalpana said talking with Pam and doing the projects helped her to not be anxious or stressed.

“If you want to feel like you’re at home and get the best holistic treatment for the whole family, come to UF Proton,” said Kalpana.

By Theresa Edwards Makrush

Over the past 12 years, the volume of published research about proton therapy has grown significantly, thanks in part to the clinical research program at the UF Health Proton Therapy Institute. Our UF Physicians lead research on proton therapy for cancers of the breast, central nervous system, head and neck, lung, pancreas, and prostate as well as lymphoma, chordoma and sarcoma. Since August 2006, we have opened 65 clinical trials. Of those, 36 have been completed and more than 174 articles have been published in peer-reviewed medical journals.

“The main purpose of the research is to document in a scientifically credible way the benefits of proton therapy,” said Nancy P. Mendenhall, MD, medical director and University of Florida professor of radiation oncology. “We think these benefits are going to be present in every single application: pediatrics, brain tumors, head and neck cancer, breast cancer, prostate cancer, lung cancer, pancreatic cancer.”  

One clinical trial that opened in 2006 and is ongoing is the Outcome Tracking Project, or OTP. Nearly all adult patients – 97% – have elected to participate and a majority of pediatric patients – 76%. This registry is an important source of data since it collects information from patients and from their medical records regarding their disease, treatment and side effects to see what effect the radiation has on them and their disease.

Much of the work in analyzing the data collected by nurse case managers and reported by patients is supported by the 11 staff members in the Research Services department. Led by Robin Cacchio, RN, CCRP, the team has a combined 40 years of proton therapy experience. They include four who are registered nurses, or RNs, and five who are certified clinical research professionals, or CCRPs.

>> Click here to learn more about clinical research at the UF Health Proton Therapy Institute.