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A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Sponsor: Candel Therapeutics, Inc.
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).
Official title: A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-10-30
Completion Date
2026-08
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
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)
Locations (7)
Academic Urology and Urogynecology of Arizona
Peoria, Arizona, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Urology Associates
Littleton, Colorado, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Sheldon Freedman, MD Ltd.
Las Vegas, Nevada, United States
Summit Health
Saddle Brook, New Jersey, United States
START Carolinas
Myrtle Beach, South Carolina, United States