Health Trials

About this trial

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 criteria

Qualifiers

Participants must give study-specific informed consent prior to enrollment

Histologically confirmed adenocarcinoma of the prostate

Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria

Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)

Disqualifiers

Active liver disease, including known cirrhosis or active hepatitis

Participants on systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs

Known HIV+ participants

Regional lymph node involvement or distant metastases

Trial design

Treatments tested in this trial

  • aglatimagene besadenovec + valacyclovir
  • External Beam Radiation Therapy (EBRT)

Treatment groups

45 Participants
are divided into 2 treatment groups

Locations

7
Arizona
Academic Urology and Urogynecology of Arizona85381, Peoria United States
Colorado
Colorado Clinical Research80228, Lakewood United States
Urology Associates80122, Littleton United States
Maryland
Chesapeake Urology Research Associates21204, Towson United States

Sponsors and collaborators

Candel Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov