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

NCT07332000 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PrTK05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Prostate Cancer Patients Treated by Radiotherapy; Prostate Cancer (Adenocarcinoma)

Keywords

Biomarkers; Viral Shedding; Prostate Cancer; Aglatimagene Besadenovec

Outcome Measures

Primary Outcomes (1)

• Biodistribution 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 Outcomes (4)

• Biomarkers of immune activation and tumor burden

  Up to 3 months post last injection of aglatimagene besadenovec.

• Biomarkers of immune activation and tumor burden

  Up to 3 months post last injection of aglatimagene besadenovec.

• Biomarkers of immune activation and tumor burden

  Up to 3 months post last injection of aglatimagene besadenovec.

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Up to 3 months post last injection of aglatimagene besadenovec.

Study Arms (2)

Treatment

EXPERIMENTAL

Patients receiving aglatimagene besadenovec + valacyclovir along with External Beam Radiation Therapy (EBRT)

Biological: aglatimagene besadenovec + valacyclovir; Radiation: External Beam Radiation Therapy (EBRT)

Control

ACTIVE COMPARATOR

External Beam Radiation Therapy (EBRT) alone

Radiation: External Beam Radiation Therapy (EBRT)

Interventions

aglatimagene besadenovec + valacyclovir BIOLOGICAL

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.

Also known as: CAN-2409 plus prodrug

Treatment

External Beam Radiation Therapy (EBRT) RADIATION

Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Candel Therapeutics, Inc.: lead

Study Sites (7)

Academic Urology and Urogynecology of Arizona

Peoria, Arizona, 85381, United States

RECRUITING

Colorado Clinical Research

Lakewood, Colorado, 80228, United States

RECRUITING

Urology Associates

Littleton, Colorado, 80122, United States

RECRUITING

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

RECRUITING

Sheldon Freedman, MD Ltd.

Las Vegas, Nevada, 89144, United States

RECRUITING

Summit Health

Saddle Brook, New Jersey, 07663, United States

RECRUITING

START Carolinas

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Valacyclovir; Prodrugs

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial contains an active treatment arm and control arm

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 12, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (7)