A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCandel Therapeutics, Inc.
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 groupsSponsors and collaborators
Source ClinicalTrials.gov