Biomarker testing in men with localized prostate cancer treated with aglatimagene besadenovec

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2a, open-label, multi-center trial enrolling men with intermediate‑risk localized prostate adenocarcinoma to receive intraprostatic injections of aglatimagene besadenovec followed by oral valacyclovir plus standard external beam radiation, with a parallel control arm receiving radiation alone. Approximately 30 participants will receive three courses of the viral vector plus valacyclovir and biospecimen collection, while about 15 control participants will provide matched biospecimens. The study will use validated qPCR assays to measure viral genomes in blood, urine, and semen and will profile immune activation using lymphocyte subsets, cytokines, and circulating tumor-related proteins. Safety and biodistribution (viral shedding) will be monitored continuously at prespecified time points before and after injections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must give study-specific informed consent prior to enrollment
2. Histologically confirmed adenocarcinoma of the prostate
3. Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
4. 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)
5. 18 years of age or older
6. Performance status must be Eastern Cooperative Oncology Group 0-2
7. The following laboratory criteria must be met (treatment group only):

   1. Aspartate aminotransferase (AST) \< 3 x upper limit of normal
   2. Serum creatinine \< 2 mg/dL
   3. Calculated creatinine clearance \> 30 mL/min
   4. White blood cells \> 3000/mm3
   5. Platelets \>100,000/mm3

Exclusion Criteria:

1. Active liver disease, including known cirrhosis or active hepatitis
2. Participants on systemic corticosteroids (\> 10 mg prednisone per day) or other immunosuppressive drugs
3. Known HIV+ participants
4. Regional lymph node involvement or distant metastases
5. Participants planning to receive whole pelvic irradiation
6. Other current malignancy (except squamous or basal cell skin cancers)
7. 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.
8. 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.
9. Participants who had or plan to have orchiectomy as the form of hormonal ablation
10. Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)

Where it's running

• Academic Urology and Urogynecology of Arizona
  Peoria, Arizona, United States Recruiting
• Colorado Clinical Research
  Lakewood, Colorado, United States Recruiting
• Urology Associates
  Littleton, Colorado, United States Recruiting
• Chesapeake Urology Research Associates
  Towson, Maryland, United States Recruiting
• Sheldon Freedman, MD Ltd.
  Las Vegas, Nevada, United States Recruiting
• Summit Health
  Saddle Brook, New Jersey, United States Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.