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Clinical Trials in the USA / NCT07332000
Recruiting Phase 2

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

NCT07332000 · tracked via the Priya Life Science USA tracker
Sponsor
Candel Therapeutics, Inc.
Phase
Phase 2
Started
2025-10-30
Last updated
2026-09-15

Condition(s) studied

Prostate Cancer Patients Treated by RadiotherapyProstate Cancer (Adenocarcinoma)

Investigational drug(s) / intervention(s)

aglatimagene besadenovec + valacyclovirExternal Beam Radiation Therapy (EBRT)

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.

External Beam Radiation Therapy (EBRT): Standard of care standard or moderately hypofractionated prostate-only external beam radiation therapy (EBRT)

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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Academic Urology and Urogynecology of Arizona Peoria Arizona Recruiting
Colorado Clinical Research Lakewood Colorado Recruiting
Urology Associates Littleton Colorado Recruiting
Chesapeake Urology Research Associates Towson Maryland Recruiting
Sheldon Freedman, MD Ltd. Las Vegas Nevada Recruiting
Summit Health Saddle Brook New Jersey Recruiting
START Carolinas Myrtle Beach South Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332000 on ClinicalTrials.gov ↗ ← All trials in the USA