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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma)

In brief

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).

Key facts

Study ID

NCT07332000

Run by

Candel Therapeutics, Inc.

People needed

45

Starts

2025-10-30

Expected to finish

2026-08-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Serum creatinine < 2 mg/dL
• Calculated creatinine clearance > 30 mL/min
• White blood cells > 3000/mm3
• Platelets >100,000/mm3

You may not qualify if…

• 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
• 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.
• Participants who had or plan to have orchiectomy as the form of hormonal ablation
• Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

Where it is running

• Academic Urology and Urogynecology of Arizona — Peoria, Arizona, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• Urology Associates — Littleton, Colorado, United States (enrolling)
• Chesapeake Urology Research Associates — Towson, Maryland, United States (enrolling)
• Sheldon Freedman, MD Ltd. — Las Vegas, Nevada, United States (enrolling)
• Summit Health — Saddle Brook, New Jersey, United States (enrolling)
• START Carolinas — Myrtle Beach, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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