A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec (NCT07332000) | Clinical Trial Compass
RecruitingPhase 2
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
United States45 participantsStarted 2025-10-30
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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)
✓. 18 years of age or older
✓. Performance status must be Eastern Cooperative Oncology Group 0-2
✓. The following laboratory criteria must be met (treatment group only):
✓. Aspartate aminotransferase (AST) \< 3 x upper limit of normal
Exclusion criteria
✕. 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
✕. Participants planning to receive whole pelvic irradiation
What they're measuring
1
Biodistribution of aglatimagene besadenovec
Timeframe: Up to 3 months post last injection of aglatimagene besadenovec.
✕. Other current malignancy (except squamous or basal cell skin cancers)
✕. Other serious co-morbid illness or compromised organ function that, in the opinion of the Investigator, would interfere with treatment or follow-up. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease.
✕. Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator.