A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Condition(s) studied
Investigational drug(s) / intervention(s)
aglatimagene besadenovec + valacyclovir: aglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally.
External Beam Radiation Therapy (EBRT): Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
Study summary
Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).
Eligibility
Primary outcome measure(s)
- Biodistribution of aglatimagene besadenovec — Up to 5 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.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Academic Urology and Urogynecology of Arizona | Peoria | Arizona | Recruiting |
| Colorado Clinical Research | Lakewood | Colorado | Recruiting |
| Urology Associates | Littleton | Colorado | Recruiting |
| Chesapeake Urology Research Associates | Towson | Maryland | Recruiting |
| Sheldon Freedman, MD Ltd. | Las Vegas | Nevada | Recruiting |
| Summit Health | Saddle Brook | New Jersey | Recruiting |
| START Carolinas | Myrtle Beach | South Carolina | Recruiting |
More Candel Therapeutics, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07332000 on ClinicalTrials.gov ↗ ← All trials in the USA