Biomarker Study of Aglatimagene Besadenovec Plus Valacyclovir in Men with Intermediate-Risk Localized Prostate Cancer Receiving Radiation Therapy

What this Trial Is About

Researchers are evaluating aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who plan to receive external beam radiation therapy EBRT. This phase 2a, open-label, multi-center study aims to assess how the treatment spreads in the body and its effects on immune activation. The study compares this combination therapy plus EBRT to EBRT alone in two groups of participants. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, each followed by a 14-day course of oral valacyclovir. EBRT will begin after the second injection. The control group will receive standard or moderately hypofractionated prostate-only EBRT alone. Biospecimens including blood, urine, and semen will be collected at specific times before and after injections or treatments to measure viral presence and immune response. Throughout the study, safety will be monitored continuously by tracking treatment-emergent adverse events and lab results. Researchers will measure the biodistribution of aglatimagene besadenovec up to three months after the last injection. They will also evaluate immune activation biomarkers and tumor-related proteins during this period. Participation includes regular sample collection and clinical assessments, with the total study duration extending up to three months post-treatment.

A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec