Actively Recruiting
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Led by Candel Therapeutics, Inc. · Updated on 2026-03-20
45
Participants Needed
7
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and 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
- For treatment group only, laboratory criteria must be met: 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 will not qualify if you...
- Active liver disease, including known cirrhosis or active hepatitis
- Use of systemic corticosteroids (> 10 mg prednisone per day) or other immunosuppressive drugs
- Known HIV positive status
- Regional lymph node involvement or distant metastases
- Planning to receive whole pelvic irradiation
- Presence of other current malignancies except squamous or basal cell skin cancers
- Serious co-morbid illness or compromised organ function that would interfere with treatment or follow-up, such as severe prostatitis or inflammatory bowel disease
- Prior treatment for prostate cancer except transurethral resection of the prostate (TURP); if prior TURP, ability to receive multiple intra-prostatic injections must be confirmed
- Prior or planned orchiectomy as hormonal ablation
- Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Academic Urology and Urogynecology of Arizona
Peoria, Arizona, United States, 85381
Actively Recruiting
2
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
3
Urology Associates
Littleton, Colorado, United States, 80122
Actively Recruiting
4
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Actively Recruiting
5
Sheldon Freedman, MD Ltd.
Las Vegas, Nevada, United States, 89144
Actively Recruiting
6
Summit Health
Saddle Brook, New Jersey, United States, 07663
Actively Recruiting
7
START Carolinas
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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