Clinical trial studies targeted radiation therapy in patients with advanced prostate cancer

University of Maryland School of Medicine (UMSOM) faculty recently launched a new clinical trial to test a targeted form of highly-focused radiation therapy in patients with advanced prostate cancer that has spread to distant sites in the body. The study, called the TERPS trial (Total Eradication of metastatic lesions following definitive Radiation to the Prostate in de novo oligometaStatic prostate cancer), aims to determine whether the innovative approach – which uses highly-focused radiation beams to carefully target small metastases – can extend survival in these patients.

"This study is targeting patients who are initially diagnosed with an advanced cancer that has begun to spread," said study co-leader Phuoc Tran, MD, PhD, Professor of Radiation Oncology and Vice Chair for Radiation Oncology Research at UMSOM. He is also a radiation oncologist at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) where the study is being conducted. "We want to see whether these patients with limited spread, called oligometastasis, experience remission and longer survival with this metastasis-directed radiation therapy."

Approximately 30,000 of American men die from prostate cancer every year. Only 32 percent of patients with metastatic prostate cancer survive for more than 5 years after their diagnosis compared to a 99 percent survival rate in patients with early-stage cancer, according to the American Cancer Society.

"Recent research suggests that targeted treatments can significantly improve outcomes for patients with oligometastatic prostate cancer where spread is limited to five or fewer small lesions that are not causing symptoms," said UMSOM Dean Mark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor. "This study highlights the importance of employing a multidisciplinary perspective that uses clinical trial data, tumor profiling and computational methods to chart the way forward for successfully treating patients with advanced-stage cancers."

This new randomized trial will compare patients who receive highly focused radiation that targets their metastases along with standard treatments to those who receive only standard treatments.

First Study Participant Remains Hopeful

After a routine procedure to treat a urinary issue, Thomas Nappi, 63, of Pasadena, was diagnosed in May 2022 with stage 4 prostate cancer. He was shocked to find his cancer had spread to his lymph nodes and spine because his regular screening test for prostate cancer, the prostate-specific antigen (PSA) test, had come back normal only weeks earlier.

Nappi was told he was not a candidate for surgery since his cancer was too advanced. In November, he decided to enroll in the TERPS trial. Nappi was randomly assigned to the treatment group where he received three treatments of highly-focused metastasis-directed therapy (MDT) at UMGCCC. He also received six weeks of proton radiation therapy at the Maryland Proton Treatment Center to kill the tumors in his prostate gland. In addition, he was prescribed standard hormonal therapy to block his testosterone, which feeds prostate cancers cells, which he will remain on for two-years.

"I actually feel fine and have had very few side effects," said Mr. Nappi, a photographer and creative services director of the Maryland Department of Human Services. He is eager to see whether the treatment keeps his cancer at bay and possibly even rids him of the disease altogether but is also grateful to have the opportunity to help researchers collect data that will benefit others. "If it's going to help somebody else in my situation, then I am happy to do that," he said.

Actively Recruiting Prostate Cancer Patients

University of Maryland researchers aim to recruit 122 study participants who were initially diagnosed with prostate cancer and had oligometastases detected in their bones or soft tissue on an imaging scan. The participants will be randomly assigned to receive a form of highly focused radiation MDT along with standard prostate cancer therapies or to receive standard treatment alone. Standard therapies will be determined by the patient's oncologist and includes radiation to the prostate gland, hormone therapy and, less often, chemotherapy. Three University of Maryland Medical System member hospitals will be recruiting for the TERPs clinical study, including UMGCCC, Tate Cancer Center at UM Baltimore Washington Medical Center and Kaufman Cancer Center at UM Upper Chesapeake Health.

"We will compare the two groups to determine whether those who receive MDT therapy have a longer survival over a two-year period," said study co-leader Zaker Rana, MD, Assistant Professor of Radiation Oncology at UMSOM. "We will also be looking to see how quickly the disease progresses over two years."

Radiation therapy that targets metastases is a relatively recent innovation that has fewer side effects than traditional chemotherapy drugs used to treat or prevent cancer spread. Unlike chemotherapy, it does not cause side-effects throughout the body. It does, however, have some local side effects, but these are generally minor and transient. Since the radiation beams can be directed at very specific sites using 3D imaging techniques, there is less likelihood of scatter to healthy tissues. This means a higher dose can be delivered to the cancerous lesion.

Patients in the control group will have the option of crossing over into the treatment group if their disease progresses or does not go into remission following their standard treatments.

For more information about this study, please email Nicole Helie at Nicole.Helie@umm.edu.