For patients with localized prostate cancer, aglatimagene besadenovec, an adenoviral-based immunotherapy, plus valacyclovir is associated with longer disease-free survival (DFS) than placebo plus valacyclovir when added to standard radiotherapy, according to a study published in the June issue of The Lancet Oncology.
Theodore L. DeWeese, M.D., from the Johns Hopkins School of Medicine in Baltimore, Maryland, and colleagues conducted a phase 3 randomized, placebo-controlled trial at 51 medical centers involving patients with intermediate- or high-risk prostate cancer who were planning to undergo external beam radiation therapy (EBRT). Participants were randomly assigned to receive three courses of intraprostatic aglatimagene plus valacyclovir (496 participants) or placebo plus valacyclovir (249 participants). Patients received standard-of-care EBRT or hypofractionated EBRT with optional androgen deprivation therapy.
The researchers found that median DFS was not reached in the aglatimagene plus valacyclovir group, compared with 86.1 months in the placebo plus valacyclovir group, after a median follow-up of 50.3 months (hazard ratio, 0.70). Treatment-emergent adverse events (TEAE) of grade 3 or worse occurred in 8 percent of participants in the aglatimagene group and 7 percent of participants in the placebo group; acute kidney injury was the most common TEAE of grade 3 or worse in both groups (2 percent in each group).
“This pivotal phase 3 trial, showing a clinically meaningful reduction in disease recurrence in patients treated with aglatimagene in combination with radiotherapy, provides important peer-reviewed validation of the significance of these findings for patients with localized prostate cancer who elect to undergo radical treatment with curative intent,” coauthor Paul Peter Tak, M.D., Ph.D., from Candel Therapeutics, said in a statement.
RELATED: Could Shorter Radiation Therapy Improve Prostate Cancer Care for Black Men?
Black men face the highest burden of prostate cancer in the United States. According to research, Black men are approximately 70 percent more likely to develop the disease and more than twice as likely to die from it compared to white men. Because of this increased risk, finding new ways to prevent prostate cancer from returning is especially important for Black men and their families.
Although the experimental immunotherapy is not widely available to the public yet, the study’s findings are promising for improving long-term outcomes for prostate cancer.
The National Cancer Institute (NCI) defines disease-free survival (DFS) as the length of time after treatment during which a person remains free of signs or symptoms of cancer. Researchers often measure DFS at 2-, 5-, or 10-year intervals to assess how effectively a treatment prevents cancer recurrence.
In this study, men who received the experimental therapy were more likely to remain cancer-free than those who received standard treatment alone, suggesting this new approach may help reduce the risk of recurrence.
The study enrolled 745 men, of whom 121 (16 percent) were Black. While this participation rate is still below the burden of disease seen among Black men, representation was better than what we typically see with most cancer trials.
Many of today’s cancer treatments have become available because patients participated in clinical trials. Increasing participation of Black people in clinical trials can help researchers determine whether new treatments work for diverse populations.
If you’d like to participate in a clinical trial, visit BlackDoctor’s Clinical Trials Resource Center.
RELATED: Prostate Cancer Clinical Trials: What Black Men Need to Know
Although more research is necessary before this new immunotherapy drug is widely available, the findings offer hope for men living with localized prostate cancer. For Black men, who face some of the highest prostate cancer risks in the nation, advances that help prevent recurrence could represent an important step toward improving long-term outcomes and survival.
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