Clinical Trials Target Radiation for Advanced Prostate Cancer

University of Maryland School of Medicine (UMSOM) faculty launched a 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 (Total Eradication of metastatic lesions following definitive Radiation to the Prostate in de novo oligometaStatic prostate cancer) trial, 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 and a radiation oncologist at the University of Maryland Marlene and Stewart 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 five 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 at 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 randomized trial will compare patients who receive highly focused radiation that targets their metastases along with standard treatments for 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 learn that 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 weeks earlier.

Nappi was told he was not a candidate for surgery since his cancer was too advanced. He decided to enroll in the TERPS trial. He was randomly assigned to the treatment group, in which 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 for a period of two-years to block his testosterone, which feeds prostate cancers cells.

"I actually feel fine and have had very few side effects," said Nappi, a photographer and creative services director for the Maryland Department of Human Services.

Nappi is eager to see whether the treatment keeps his cancer at bay and possibly rids him of the disease altogether. He is also grateful for the opportunity to help researchers collect information that can 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 (UMMS) hospitals will be recruiting for the TERPs clinical study, including UMGCCC, the Tate Cancer Center at University of Maryland Baltimore Washington Medical Center and the Kaufman Cancer Center at University of Maryland 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, meaning 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.