NCT07332000 · Candel Therapeutics, Inc.
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
What this study is about
Phase 2a, where both patients and doctors know the treatment given, 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).
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Serum creatinine \< 2 mg/dL
- Calculated creatinine clearance \> 30 mL/min
- White blood cells \> 3000/mm3
- Platelets \>100,000/mm3
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
- 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
- Peoria, Arizona
- Lakewood, Colorado
- Littleton, Colorado
- Towson, Maryland
- Las Vegas, Nevada
- Saddle Brook, New Jersey
- Myrtle Beach, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations