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

Last updated: March 19, 2026
Sponsor: Candel Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

aglatimagene besadenovec + valacyclovir

External Beam Radiation Therapy (EBRT)

Clinical Study ID

NCT07332000
PrTK05
  • Ages > 18
  • Male

Study Summary

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).

Eligibility Criteria

Inclusion

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-riskcriteria

  4. Participants must be planning and medically able to undergo standard or moderatehypofractionated prostate-only EBRT (treatment and control group) and able totolerate 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):

  8. Aspartate aminotransferase (AST) < 3 x upper limit of normal

  9. Serum creatinine < 2 mg/dL

  10. Calculated creatinine clearance > 30 mL/min

  11. White blood cells > 3000/mm3

  12. Platelets >100,000/mm3

Exclusion

Exclusion Criteria:

  1. Active liver disease, including known cirrhosis or active hepatitis

  2. Participants on systemic corticosteroids (> 10 mg prednisone per day) or otherimmunosuppressive 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 opinionof the Investigator, would interfere with treatment or follow-up. For example,participants with diseases that preclude radiation therapy to the prostate such assevere 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 multipleintra-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 (treatmentgroup only)

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: aglatimagene besadenovec + valacyclovir
Phase: 2
Study Start date:
October 30, 2025
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Academic Urology and Urogynecology of Arizona

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Urology Associates

    Littleton, Colorado 80122
    United States

    Active - Recruiting

  • Chesapeake Urology Research Associates

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Chesapeake Urology Research Associates

    Towson 4371582, Maryland 4361885 21204
    United States

    Site Not Available

  • Sheldon Freedman, MD Ltd.

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

  • Sheldon Freedman, MD Ltd.

    Las Vegas 5506956, Nevada 5509151 89144
    United States

    Site Not Available

  • Summit Health

    Saddle Brook, New Jersey 07663
    United States

    Active - Recruiting

  • Summit Health

    Saddle Brook 5103637, New Jersey 5101760 07663
    United States

    Site Not Available

  • START Carolinas

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

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