Actively Recruiting
A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec
Led by Candel Therapeutics, Inc. · Updated on 2026-03-20
45
Participants Needed
7
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who plan to receive external beam radiation therapy (EBRT). This phase 2a, open-label, multi-center study aims to assess how the treatment spreads in the body and its effects on immune activation. The study compares this combination therapy plus EBRT to EBRT alone in two groups of participants. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, each followed by a 14-day course of oral valacyclovir. EBRT will begin after the second injection. The control group will receive standard or moderately hypofractionated prostate-only EBRT alone. Biospecimens including blood, urine, and semen will be collected at specific times before and after injections or treatments to measure viral presence and immune response. Throughout the study, safety will be monitored continuously by tracking treatment-emergent adverse events and lab results. Researchers will measure the biodistribution of aglatimagene besadenovec up to three months after the last injection. They will also evaluate immune activation biomarkers and tumor-related proteins during this period. Participation includes regular sample collection and clinical assessments, with the total study duration extending up to three months post-treatment.
CONDITIONS
Brief 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
- Meet National Comprehensive Cancer Network (NCCN) intermediate-risk criteria
- Planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT
- 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
- For treatment group only, lab criteria: AST less than 3 times upper limit of normal
- Serum creatinine less than 2 mg/dL
- Calculated creatinine clearance greater than 30 mL/min
- White blood cells greater than 3000/mm3
- Platelets greater than 100,000/mm3
You will not qualify if you...
- Active liver disease including known cirrhosis or active hepatitis
- Use of systemic corticosteroids greater than 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 malignancy except squamous or basal cell skin cancers
- Serious co-morbid illness or compromised organ function interfering with treatment or follow-up
- Prior prostate cancer treatment except transurethral resection of the prostate (TURP) unless able to receive multiple injections
- History or planned orchiectomy as hormonal ablation
- Known sensitivity or allergy to acyclovir or valacyclovir (treatment group only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 3 injections and associated valacyclovir courses plus EBRT (several weeks)
Participants in the treatment group receive 3 intraprostatic injections of aglatimagene besadenovec, each followed by a 14-day course of oral valacyclovir. External beam radiation therapy (EBRT) starts after the second injection. Participants in the control group receive EBRT alone. Biospecimens such as blood, urine, and semen are collected before and after each injection or at specified timepoints in the control group to assess biodistribution and immune response.
Multiple visits for injections, valacyclovir administration, EBRT sessions, and biospecimen collection
Duration - Up to 3 months post last injection or post EBRT
Participants are monitored for safety and biomarker assessment for up to 3 months after the last injection of aglatimagene besadenovec or completion of EBRT. This includes monitoring for treatment-emergent adverse events and collection of biospecimens to assess immune activation and tumor burden.
Periodic visits during follow-up for safety monitoring and biospecimen collection
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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