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RECRUITING
NCT07332000
PHASE2

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

Sponsor: Candel Therapeutics, Inc.

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

RADIATION

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