A Biomarker Study for Prostate Cancer Treated with Aglatimagene Besadenovec
This study is looking at men with localized, intermediate-risk prostate cancer who are planning to receive radiation therapy. It's testing a treatment called aglatimagene besadenovec, which is a modified virus, given with valacyclovir (an antiviral medicine). The researchers want to understand how aglatimagene besadenovec spreads in the body and how it affects the immune system. Some participants will receive aglatimagene besadenovec plus valacyclovir and radiation, while others will receive radiation alone. The main goal is to see where aglatimagene besadenovec goes in the body up to three months after the last injection. You may be able to join if you have prostate adenocarcinoma and meet specific risk criteria. The study aims to enroll about 45 men.
- Study design
- This is a Phase 2a, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves about 45 participants across multiple centers.
- What's involved
- If you are in the treatment arm, you will receive three injections of aglatimagene besadenovec into your prostate, along with oral valacyclovir. Blood, urine, and semen samples will be collected at various times before and after each injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- The biodistribution of aglatimagene besadenovec will be measured for up to 3 months after the last injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
At a glance
Conditions
Where it's being run
7 sites across 6 statesWho to contact
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What this trial measures
- Biodistribution of aglatimagene besadenovecUp to 3 months post last injection of aglatimagene besadenovec.
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.