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

March 19, 2026 updated by: Candel Therapeutics, Inc.

A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase 2a, open-label, multi-center study evaluating aglatimagene besadenovec plus prodrug in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT). Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral antiviral prodrug (valacyclovir), this approach induces targeted tumor cell death and stimulates a systemic immune response. The study aims to characterize:

  • Viral shedding and biodistribution of CAN-2409 genomes in blood, urine, and semen using validated qPCR assays.
  • Immune activation biomarkers, including lymphocyte subsets, cytokine profiles, and circulating tumor-related proteins.

Approximately 30 patients with intermediate risk prostate cancer will be recruited to the treatment arm and receive 3 courses of aglatimigene besadenovec by intraprostatic injection followed by orally administered valacyclovir. EBRT will start following the second injection. Biospecimens (blood, urine, semen) will be collected at specifed timepoints before and after each injection to assess biodistribution and immune response.

Approzimately 15 patients with intermediate risk prostate cancer will be recruited to the control arm receiving EBRT alone. Biospecimens (blood, urine, semen) will be collected at specified timepoints to assess immune response.

Safety will be monitored continuously. Frequency of treatment-emergent adverse events (TEAEs) and laboratory values will be evaluated for patients in the treatment arm. Patients in the control arm will be monitored for treatment-emergent serious adverse events suspected to be related to the collection of biospecimens.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Academic Urology and Urogynecology of Arizona
        • Contact:
        • Principal Investigator:
          • Chandan Kundavaram, M.D.
    • Colorado
      • Lakewood, Colorado, United States, 80228
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Urology Associates
        • Contact:
        • Principal Investigator:
          • James Fagelson, M.D.
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology Research Associates
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronald Tutrone, M.D.
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Sheldon Freedman, MD Ltd.
        • Contact:
        • Principal Investigator:
          • Sheldon Freedman, M.D.
    • New Jersey
      • Saddle Brook, New Jersey, United States, 07663
        • Recruiting
        • Summit Health
        • Contact:
        • Principal Investigator:
          • Glen Gejerman, M.D.
    • South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT)
Biological: aglatimagene besadenovec + valacyclovir
aglatimagene besadenovec: a genetically modified replication-defective adenoviral vector expressing the herpes simplex virus (HSV) thymidine kinase (tk) gene. Patients in the treatment arm will receive 3 intraprostatic injections of aglatimagene besadenovec, with each injection followed by a 14-day course of valacyclovir. Patients will have aglatimagene besadenovec administered either transrectally or transperineally.
Other Names:
  • CAN-2409 plus prodrug
Radiation: External Beam Radiation Therapy (EBRT)
Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)
Active Comparator: Control
External Beam Radiation Therapy (EBRT) alone
Radiation: External Beam Radiation Therapy (EBRT)
Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biodistribution of aglatimagene besadenovec
Time Frame: Up to 3 months post last injection of aglatimagene besadenovec.
Evaluation of shedding of aglatimagene besadenovec viral genomes in urine, blood, and semen samples using validated bioassays over time.
Up to 3 months post last injection of aglatimagene besadenovec.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biomarkers of immune activation and tumor burden
Time Frame: Up to 3 months post last injection of aglatimagene besadenovec.
Evaluation of prostate-specific antigen (PSA) ng/mL changes over time.
Up to 3 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Time Frame: Up to 3 months post last injection of aglatimagene besadenovec.
Evaluation of changes in lymphocytes as a proportion of total immune cells over time (lymphocytes/PBMCs).
Up to 3 months post last injection of aglatimagene besadenovec.
Biomarkers of immune activation and tumor burden
Time Frame: Up to 3 months post last injection of aglatimagene besadenovec.
Changes from baseline in concentrations of circulating proteins (e.g. Olink Normalized Protein Expression, or NPX).
Up to 3 months post last injection of aglatimagene besadenovec.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: Up to 3 months post last injection of aglatimagene besadenovec.
Up to 3 months post last injection of aglatimagene besadenovec.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Candel Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PrTK05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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